Recall events
/
Event 87512
Event summary
Timeline bucket March 15, 2021
Product types Drug
Classifications Class II
Statuses Terminated
Recalling firm wording Cardinal Health Inc.
Dossier provenance
Source snapshots represented here
openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Device root-cause evidence is not applicable to this event.
No grouped product has the official product type device; this is not an unavailable-enrichment finding.
Complete imported group
Every recalled product in this event
198 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 198
THERAPEUTIC M 130; NDC/UPC 740985223680; OTC; TABLETS
D-0400-2021
Recall number D-0400-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 55 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13724]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 198
NIACIN 250MG 110; NDC/UPC 740985228494; OTC; TABLETS
D-0401-2021
Recall number D-0401-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 4 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13351]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 198
Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP Units Rx only NDC 0032-3016-13 100 Capsules Marketed by: AbbVie Inc. North Chicago, IL 60064, U.S.A.
D-0402-2021
Recall number D-0402-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 1669 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17490]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 198
Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium, 28 Tablets For 28 Days Rx only NDC 0074-0038-28 Each carton contains 28 tablets in 4 weekly blister pack, Each weekly blister pack contains 7 tablets of elagolix 150 mg AbbVie Inc. North Chicago, IL 60064
D-0403-2021
Recall number D-0403-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 210 cartons
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15744]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 198
Norvir Ritonavir Tablets 100 mg 30 Tablets Rx only NDC 0074-3333-30 Abbott Laboratories North Chicago, IL 60064, U.S.A.
D-0404-2021
Recall number D-0404-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 362 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15337]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 198
Synthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles and concentrations Rx only Abbott Laboratories North Chicago, IL
D-0405-2021
Recall number D-0405-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 123 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13777]
FDA event record
· Exact recall-number query on openFDA
drug · product 7 of 198
METHOCARBAMOL 500MG 500; NDC/UPC 71093014005; RX; TABLETS
D-0406-2021
Recall number D-0406-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 51 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information UMETA0036A
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13734]
FDA event record
· Exact recall-number query on openFDA
drug · product 8 of 198
FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04; RX; CAPSULES
D-0407-2021
Recall number D-0407-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 106 BOXES
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15514]
FDA event record
· Exact recall-number query on openFDA
drug · product 9 of 198
OFLOXACIN 0.3% 5ML OPTH; NDC/UPC 17478071310; RX; DROPS
D-0408-2021
Recall number D-0408-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 339 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13299]
FDA event record
· Exact recall-number query on openFDA
drug · product 10 of 198
LIDOCAINE HCL VISC 2% 100ML; NDC/UPC 50383077504; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS)
D-0409-2021
Recall number D-0409-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 240 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13822]
FDA event record
· Exact recall-number query on openFDA
drug · product 11 of 198
Atropine Sulfate Ophthalmic Solution, USP 1% For Topical Application To The Eye Sterile 5 mL Rx only NDC 17478-215-05 Manufactured by: Akorn, Inc.
D-0410-2021
Recall number D-0410-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 424 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13782]
FDA event record
· Exact recall-number query on openFDA
drug · product 12 of 198
COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolamide Hydrochloride 22.3 mg/mL Timolol Maleate 6.8 mg/mL) 10ML Ocumeter Plus Ophthalmic Dispenser Sterile Ophthlamic Solution Rx only NDC/UPC 174780-605-10 Distributed by: Akorn, Inc. Lake Forest, IL 60045
D-0411-2021
Recall number D-0411-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 12 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13310]
FDA event record
· Exact recall-number query on openFDA
drug · product 13 of 198
Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg 100 Tablets Rx only NDC 62332-115-31 Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA
D-0412-2021
Recall number D-0412-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 71 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information 2005005745
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17513]
FDA event record
· Exact recall-number query on openFDA
drug · product 14 of 198
BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS
D-0413-2021
Recall number D-0413-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 152 CARTON
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14357]
FDA event record
· Exact recall-number query on openFDA
drug · product 15 of 198
Vaniqa (eflornithine hydrochloride) Cream, 13.9% For Topical Use Only Net wt. 1.59 oz (45 g) Rx only NDC 0023-4857-45 Manufactured for Allegan, Inc. Irvine, CA 92612
D-0414-2021
Recall number D-0414-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 72 tubes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13306]
FDA event record
· Exact recall-number query on openFDA
drug · product 16 of 198
UBRELVY 100MG 10UD CPLT; NDC/UPC 23650110; RX; TABLETS
D-0415-2021
Recall number D-0415-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 964 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13778]
FDA event record
· Exact recall-number query on openFDA
drug · product 17 of 198
RESTASIS 0.05%30X 0.4ML OPTH PF; NDC/UPC 23916330; RX; DROPS/Restasis 0.05% 60x0.4 mL OPTH PF; NDC/UPC 23916330; RX
D-0416-2021
Recall number D-0416-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 3688 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13661]
FDA event record
· Exact recall-number query on openFDA
drug · product 18 of 198
Linzess (linaclotide) capsules 72 mcg/capsule 30 capsules Rx Only NDC 0456-1203-30 Distributed by: Allergan USA, Inc. Irvine, CA 92612
D-0417-2021
Recall number D-0417-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 1529 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17533]
FDA event record
· Exact recall-number query on openFDA
drug · product 19 of 198
Namzaric (memantine HCl extended release and donepezil HCl) capsules 14 mg/10 mg per capsule 30 capsules Rx Only NDC 0456-1214-30 Distributed by Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, LLC.
D-0418-2021
Recall number D-0418-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 659 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[101]
FDA event record
· Exact recall-number query on openFDA
drug · product 20 of 198
Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only 30 g Rx Only NDC 58914-301-80 Mfd. by: Pharbil Waltrop GmbH, Im Wirrigen 25, 45731 Waltrop, Germany Distributed by: Aptalis Pharma US, Inc. Birmingham, AL 35242
D-0419-2021
Recall number D-0419-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 31 tubes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15976]
FDA event record
· Exact recall-number query on openFDA
drug · product 21 of 198
Vraylar (cariprazine) capsules in all pack sizes, styles and strengths Rx only Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
D-0420-2021
Recall number D-0420-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 759 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13325]
FDA event record
· Exact recall-number query on openFDA
drug · product 22 of 198
Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only NDC 47781-306-01 Manufactured by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 Distributed by: Alvogen, Inc. Parsippany, NJ 07054 U.S.A.
D-0421-2021
Recall number D-0421-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 15 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16185]
FDA event record
· Exact recall-number query on openFDA
drug · product 23 of 198
BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM 4MG/1MG 30 POUCHES EACH CONTAINING 1 SUBLINGUAL FILM NDC/UPC 47781-0356-03; RX; FILM
D-0422-2021
Recall number D-0422-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 249 CARTONS
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13308]
FDA event record
· Exact recall-number query on openFDA
drug · product 24 of 198
Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL contains 6 mg oseltamivir base after constitution. 60 mL (usable volume after constitution) Rx Only NDC 47781-384-26 Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA
D-0423-2021
Recall number D-0423-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 15885 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14778]
FDA event record
· Exact recall-number query on openFDA
drug · product 25 of 198
ERYTHROMYCIN TABLETS, USP 250MG 30; NDC/UPC 69238-1484-3; RX; TABLETS
D-0424-2021
Recall number D-0424-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 135 CARTON
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16370]
FDA event record
· Exact recall-number query on openFDA
drug · product 26 of 198
TRAVOPROST OPHTHALMIC SOLUTION, USP 0.004% 2.5ML ; NDC/UPC 60505-0593-4; RX; DROPS
D-0425-2021
Recall number D-0425-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 325 CARTONS
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16060]
FDA event record
· Exact recall-number query on openFDA
drug · product 27 of 198
ENOXAPARIN DOFIUM INJRVYION, UPD 150MG/1ML 10X1ML SINGLE DOSE SYRINGES; NDC/UPC 60505-0798-4; RX; SYRINGES
D-0426-2021
Recall number D-0426-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 64 BOXES
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14106]
FDA event record
· Exact recall-number query on openFDA
drug · product 28 of 198
Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles Rx Only NDC 60505-0813-1 Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9
D-0427-2021
Recall number D-0427-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 38 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15330]
FDA event record
· Exact recall-number query on openFDA
drug · product 29 of 198
Timolol Maleate Ophthalmic Solution, USP 0.5% 2.5 mL Sterile For Topical Application In The Eye Rx Only NDC 60505-1005-4 Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326
D-0428-2021
Recall number D-0428-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 31 droptainers
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14866]
FDA event record
· Exact recall-number query on openFDA
drug · product 30 of 198
Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328
D-0429-2021
Recall number D-0429-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 328 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14175]
FDA event record
· Exact recall-number query on openFDA
drug · product 31 of 198
edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/12.5 mg 30 Tablets Rx Only NDC 60631-412-30 Manufactured for: arbor Pharmaceuticals, LLC. Atlanta, GA 30328
D-0430-2021
Recall number D-0430-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 244 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14443]
FDA event record
· Exact recall-number query on openFDA
drug · product 32 of 198
edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/25 mg *Each tablet contains: 42.68 mg azilsartan kamedoxomil (equivalent to 40 mg azilsartan medoxomil) and 25 mg chlorthalidone. 30 Tablets Rx Only NDC 60631-425-30 Manufactured for Arbor Pharmaceuticals Atlanta, GA 30328
D-0431-2021
Recall number D-0431-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 273 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14178]
FDA event record
· Exact recall-number query on openFDA
drug · product 33 of 198
GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL
D-0432-2021
Recall number D-0432-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 3 CARTON
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[75]
FDA event record
· Exact recall-number query on openFDA
drug · product 34 of 198
Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC 0186-0776-60 Mfd. for: AstraZeneca LP, Wilmington, DE 19850
D-0433-2021
Recall number D-0433-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 1278 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17514]
FDA event record
· Exact recall-number query on openFDA
drug · product 35 of 198
Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol 9 mcg/4.8 mcg per inhalation For Oral Inhalation only 120 inhalations Rx Only NDC 0310-4600-12 Mfd for: AstraZeneca Pharmaceuticals, LP, Wilmington, DE 19850
D-0434-2021
Recall number D-0434-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 355 inhalers
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information 6030180A00
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15644]
FDA event record
· Exact recall-number query on openFDA
drug · product 36 of 198
xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx only NDC 0310-6280-30 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Manufactured by: Bristol-Myers Squibb Manufacturing Company Humacao, Puerto Rico 00791
D-0435-2021
Recall number D-0435-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 664 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17777]
FDA event record
· Exact recall-number query on openFDA
drug · product 37 of 198
xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablets Rx only NDC 0310-6260-60 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850
D-0436-2021
Recall number D-0436-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 378 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17135]
FDA event record
· Exact recall-number query on openFDA
drug · product 38 of 198
IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML ; NDC/UPC 59651-032-12; RX; SUSPENSION (NO DROPS)
D-0437-2021
Recall number D-0437-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 345 CARTONS
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information BO1020069-A
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17291]
FDA event record
· Exact recall-number query on openFDA
drug · product 39 of 198
Eletriptan Hydrobromide Tablets 20 mg* 6(1x6) Unit-dose Tablets Rx only NDC 59651-104-69 Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520
D-0438-2021
Recall number D-0438-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 20 CARTONS
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information EA2020001-A
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13711]
FDA event record
· Exact recall-number query on openFDA
drug · product 40 of 198
AMOXICILLIN 500MG 100; NDC/UPC 65862001401; RX; TABLETS
D-0439-2021
Recall number D-0439-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 373 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information SE5019062-A
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13303]
FDA event record
· Exact recall-number query on openFDA
drug · product 41 of 198
ONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETS
D-0440-2021
Recall number D-0440-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 1935 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information ON0420015-A
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13726]
FDA event record
· Exact recall-number query on openFDA
drug · product 42 of 198
ESZOPICLONE 3MG 100 C4; NDC/UPC 65862096901; RX; TABLETS
D-0441-2021
Recall number D-0441-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 29 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information GS0320010-A
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13300]
FDA event record
· Exact recall-number query on openFDA
drug · product 43 of 198
Nuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60 capsules Rx only NDC 64597-301-60 Manufactured by Patheon, Inc. Whitby, ON L1N 5Z5, Canada
D-0442-2021
Recall number D-0442-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 255 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16099]
FDA event record
· Exact recall-number query on openFDA
drug · product 44 of 198
LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM; NDC/UPC 24208-0507-07; RX; GEL
D-0443-2021
Recall number D-0443-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 463 boxes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13611]
FDA event record
· Exact recall-number query on openFDA
drug · product 45 of 198
BENZEFOAM EMOLLIENT FOAM BENZOYL PEROXIDE 5.3% 100GM TOP EMOL NDC 187-0194--10; OTC; FOAMS
D-0444-2021
Recall number D-0444-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 2 carton
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13766]
FDA event record
· Exact recall-number query on openFDA
drug · product 46 of 198
MURO-128 2% 15ML OPTH; NDC/UPC 324208276150; OTC; DROPS
D-0445-2021
Recall number D-0445-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 64 droptainers
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13371]
FDA event record
· Exact recall-number query on openFDA
drug · product 47 of 198
TOBRAMY/DEX 0.3-0.1% 10ML OPTH; NDC/UPC 24208029510; RX; DROPS
D-0446-2021
Recall number D-0446-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 47 droptainers
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13663]
FDA event record
· Exact recall-number query on openFDA
drug · product 48 of 198
DEXAMETH SOD PHOS 0.1% 5ML; NDC/UPC 24208072002; RX; DROPS
D-0447-2021
Recall number D-0447-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 318 droptainers
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13714]
FDA event record
· Exact recall-number query on openFDA
drug · product 49 of 198
Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-023-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612.
D-0448-2021
Recall number D-0448-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 96 cartons
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[429]
FDA event record
· Exact recall-number query on openFDA
drug · product 50 of 198
Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-025-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612 USA
D-0449-2021
Recall number D-0449-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 47 cartons
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information BL6002004
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16116]
FDA event record
· Exact recall-number query on openFDA
drug · product 51 of 198
SYMPROIC (NAIDEMEDINE) TABLETS 0.2MG 30 TABLETS; NDC 59385-041-30; RX; TABLETS
D-0450-2021
Recall number D-0450-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 67 BOXES
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14824]
FDA event record
· Exact recall-number query on openFDA
drug · product 52 of 198
NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAPID DISSOLUTION (NOT SUBLINGUAL)
D-0451-2021
Recall number D-0451-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 1240 CARTON
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17476]
FDA event record
· Exact recall-number query on openFDA
drug · product 53 of 198
CATAPRES-TTS-2 1X4; NDC/UPC 597003234; RX; ADHESIVE PATCHES
D-0452-2021
Recall number D-0452-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 17 patches
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information 1905666/2
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13354]
FDA event record
· Exact recall-number query on openFDA
drug · product 54 of 198
Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg (as tiotropium) per capsule Rx only NDC 0597-0075-41 Manufactured by: Boehringer Ingelheim (BI) Pharma GmbH & Co. KG Ingelheim, Germany Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA and Pfizer, Inc. New York, NY 10017 USA
D-0453-2021
Recall number D-0453-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 2611 inhalers
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16179]
FDA event record
· Exact recall-number query on openFDA
drug · product 55 of 198
ATROVENT HFA 17MCG 12.9GM; NDC/UPC 597008717; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
D-0454-2021
Recall number D-0454-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 667 inhalers
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13775]
FDA event record
· Exact recall-number query on openFDA
drug · product 56 of 198
Glyxambi (empagliflozin and linagliptin) Tablets 25 mg/5 mg 30 tablets Rx only NDC 0597-0164-30 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA
D-0455-2021
Recall number D-0455-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 592 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16467]
FDA event record
· Exact recall-number query on openFDA
drug · product 57 of 198
Synjardy (empagliflozin and metformin hydrochloride) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0168-69 Distributed by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA
D-0456-2021
Recall number D-0456-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 284 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13731]
FDA event record
· Exact recall-number query on openFDA
drug · product 58 of 198
Jentadueto XR (linagliptin and metformin hydrochloride extended-release) Tablets 5 mg/1000 mg 30 tablets Rx only NDC 0597-0275-33 Dist. by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA
D-0457-2021
Recall number D-0457-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 52 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17666]
FDA event record
· Exact recall-number query on openFDA
drug · product 59 of 198
Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/1000 mg 30 tablets Rx only NDC 0597-0295-88 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA
D-0458-2021
Recall number D-0458-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 269 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16807]
FDA event record
· Exact recall-number query on openFDA
drug · product 60 of 198
Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0300-45 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA
D-0459-2021
Recall number D-0459-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 751 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17559]
FDA event record
· Exact recall-number query on openFDA
drug · product 61 of 198
PRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETS
D-0460-2021
Recall number D-0460-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 3 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information ABA4203A1
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13752]
FDA event record
· Exact recall-number query on openFDA
drug · product 62 of 198
Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC 59746-360-30 Manufactured by: Jubilant Generics Ltd. Roorkee-247661, India
D-0461-2021
Recall number D-0461-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 20 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information VR120022A
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14934]
FDA event record
· Exact recall-number query on openFDA
drug · product 63 of 198
Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser (sodium sulfacetamide 9.8% and sulfur 4.8%) Net Wt. 10 oz. (285 g) Rx Only NDC 50096-502-10 Manufactured for: Rosemar Labs, LLC 2100 West Loop South Suite 900 Houston, TX 77027
D-0462-2021
Recall number D-0462-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 16 tubes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13792]
FDA event record
· Exact recall-number query on openFDA
drug · product 64 of 198
Meloxicam Tablets, USP 7.5 mg 100 Tablets Rx Only NDC 69097-158-07 Manufactured for: Cipla USA, Inc. 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156
D-0463-2021
Recall number D-0463-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 576 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16221]
FDA event record
· Exact recall-number query on openFDA
drug · product 65 of 198
Nadolol Tablets, USP 40 mg 100 Tablets Rx Only NDC 69097-868-07 Manufactured for: Cipla USA Inc. 9100 S. Dadeland Blvd., Suite 1599 Miami, FL 33156
D-0464-2021
Recall number D-0464-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 40 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13728]
FDA event record
· Exact recall-number query on openFDA
drug · product 66 of 198
CIPROFLOX/D5W 400/200 24X200ML; NDC/UPC 36000000924; RX; IV SOLUTION (PIGGYBACK)
D-0465-2021
Recall number D-0465-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 40 bags
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13762]
FDA event record
· Exact recall-number query on openFDA
drug · product 67 of 198
Prilosec (Omeprazole Magnesium) For Delayed-Release Oral Suspension 10 mg Rx only NDC 70515-610-01 Mfd. for: Covis Pharma, Zug, 6300 Switzerland
D-0466-2021
Recall number D-0466-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 13 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13316]
FDA event record
· Exact recall-number query on openFDA
drug · product 68 of 198
Iron 100 with Vitamin C Tablets Dietary Supplement 100 Tablets NDC 60258-099-01 Distributed By: Cypress Pharmaceutical, Inc. 135 Industrial Blvd. Madison, MS 39110
D-0467-2021
Recall number D-0467-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 1 bottle
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13706]
FDA event record
· Exact recall-number query on openFDA
drug · product 69 of 198
BENICAR 40MG 30; NDC/UPC 65597010430; RX; TABLETS
D-0468-2021
Recall number D-0468-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 75 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13755]
FDA event record
· Exact recall-number query on openFDA
drug · product 70 of 198
PREGABALIN CAPSULES 300MG 90 ; NDC 43598-298-90; RX; CAPSULES
D-0469-2021
Recall number D-0469-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 6 CONTAINERS
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17509]
FDA event record
· Exact recall-number query on openFDA
drug · product 71 of 198
Phenobarbital Tablets, USP 32.4 mg 100 tablets Rx only NdC 13517-111-01 Manufactured for: e5 Pharma, LLC., Boca Raton, FL 33432
D-0470-2021
Recall number D-0470-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 1 bottle
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15678]
FDA event record
· Exact recall-number query on openFDA
drug · product 72 of 198
Ivermectin Tablets USP 3 mg 20 Tablets (2 Foil Strips of 10 tablets each) Rx Only NDC 4799-806-01 Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054 877-381-3336
D-0471-2021
Recall number D-0471-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 504 cartons
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information A1003273A
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13743]
FDA event record
· Exact recall-number query on openFDA
drug · product 73 of 198
Banzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manufactured by Eisai Co., Ltd. Marketed by Eisai Inc. Woodcliff Lake, NJ 07677
D-0472-2021
Recall number D-0472-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 30 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14402]
FDA event record
· Exact recall-number query on openFDA
drug · product 74 of 198
Narcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box contains two (2) 4-mg doses of naloxone HCl in 0.1 mL of nasal spray. 0.1 mL intranasal spray per unit For use in the nose only Rx only NDC 69547-353-02 Distributed by Adapt Pharma, Inc. Radnor, PA 19087 USA
D-0473-2021
Recall number D-0473-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 11189 plungers
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15382]
FDA event record
· Exact recall-number query on openFDA
drug · product 75 of 198
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP 10-30-2MG/5ML 473ML; NDC/UPC 71930-026-43; RX; SYRUP
D-0474-2021
Recall number D-0474-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 73 carton
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information 13120103A
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17263]
FDA event record
· Exact recall-number query on openFDA
drug · product 76 of 198
Prenatal Tablets Gluten Free Multivitamin/ Multimineral Dietary Supplement for Pregnant and Lactating Women UD 100 Tablets (10x10) NDC 77333-715-10 GenDose Pharmaceuticals
D-0475-2021
Recall number D-0475-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 41 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13368]
FDA event record
· Exact recall-number query on openFDA
drug · product 77 of 198
cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 Genentech
D-0476-2021
Recall number D-0476-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 1473 vials
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17060]
FDA event record
· Exact recall-number query on openFDA
drug · product 78 of 198
FLOVENT DISKUS 100MCG 60; NDC/UPC 173060202; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
D-0477-2021
Recall number D-0477-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 237 inhalers
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13760]
FDA event record
· Exact recall-number query on openFDA
drug · product 79 of 198
ADVAIR HFA 45-21MCG 12GM; NDC/UPC 173071520; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
D-0478-2021
Recall number D-0478-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 297 inhalers
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13809]
FDA event record
· Exact recall-number query on openFDA
drug · product 80 of 198
ARNUITY ELLIPTA 100MCG 30INH; NDC/UPC 173087410; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
D-0479-2021
Recall number D-0479-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 513 inhalers
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13773]
FDA event record
· Exact recall-number query on openFDA
drug · product 81 of 198
Arnuity Ellipta (fluticasone furoate inhalation powder) 200 mcg 1 Ellipta Inhaler containing 1 Foil Strip of 30 Blisters Rx Only NDC 0173-0876-10 GlaxoSmithKline Research Triangle Park, NC 27709
D-0480-2021
Recall number D-0480-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 353 inhalers
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14968]
FDA event record
· Exact recall-number query on openFDA
drug · product 82 of 198
TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMEDIDINIUM AND VILANTEROL INHALATION POWDER) 100-62.5-25MCG 60; NDC/UPC 0173-0893-10; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
D-0481-2021
Recall number D-0481-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 4065 CARTON
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17655]
FDA event record
· Exact recall-number query on openFDA
drug · product 83 of 198
Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) 100 mcg/62.5 mcg/25 mcg; 1 ELLIPTA Inhaler containing 30 doses (60 blisters total) Rx Only NDC 0173-0887-10 GlaxoSmithKline Research Triangle Park, NC 27709
D-0482-2021
Recall number D-0482-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 903 inhalers
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17485]
FDA event record
· Exact recall-number query on openFDA
drug · product 84 of 198
Verapamil Hydrochloride Extended-Release Tablets USP 120 mg Rx Only NDC 68462-292-01 Manufactured by: Glenmark Generics Ltd Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Generics Inc., USA Mahwah, NJ 07430
D-0483-2021
Recall number D-0483-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 513 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16368]
FDA event record
· Exact recall-number query on openFDA
drug · product 85 of 198
EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETS
D-0484-2021
Recall number D-0484-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 7 CARTON
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17556]
FDA event record
· Exact recall-number query on openFDA
drug · product 86 of 198
Theophylline (Anhydrous) Extended-Release Tablets 400 mg 100 Tablets Rx Only NDC 68462-380-01 Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
D-0485-2021
Recall number D-0485-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 141 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16835]
FDA event record
· Exact recall-number query on openFDA
drug · product 87 of 198
Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets 30 Tablets Rx Only NDC 49702-231-13 Manufactured for: Viiv Healthcare Research Triangle Park, NC 27709 by GlaxoSmithKline Research Triangle Park, NC 27709
D-0486-2021
Recall number D-0486-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 2264 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16803]
FDA event record
· Exact recall-number query on openFDA
drug · product 88 of 198
Hydrocortisone Ointment USP 1% Maximum Strength Net Wt. 1 oz (28 g) NDC 0472-0345-56 Manufactured by: Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28902
D-0487-2021
Recall number D-0487-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 23 tubes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13735]
FDA event record
· Exact recall-number query on openFDA
drug · product 89 of 198
FaBB Vitamin B6 (as Pyridoxine Hydrochloride) 25 mg Folic Acid 2.2 mg Vitamin B12 (as Cyanocobalamin) 1.0 mg Dietary Supplement 100 Tablets Distributed by: H2-Pharma, LLC 2010 Berry Chase Place Montgomery, AL 36117
D-0488-2021
Recall number D-0488-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 54 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13301]
FDA event record
· Exact recall-number query on openFDA
drug · product 90 of 198
bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724
D-0489-2021
Recall number D-0489-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 32 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15904]
FDA event record
· Exact recall-number query on openFDA
drug · product 91 of 198
AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724
D-0490-2021
Recall number D-0490-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 122 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17288]
FDA event record
· Exact recall-number query on openFDA
drug · product 92 of 198
Calcium Acetate Capsules 667 mg 200 Capsules Rx only NDC 23155-531-02 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724
D-0491-2021
Recall number D-0491-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 35 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14515]
FDA event record
· Exact recall-number query on openFDA
drug · product 93 of 198
LITHIUM CARB 150MG 100; NDC/UPC 54252625; RX; CAPSULES
D-0492-2021
Recall number D-0492-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 298 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13747]
FDA event record
· Exact recall-number query on openFDA
drug · product 94 of 198
LEUCOVORIN 15MG 24; NDC/UPC 54449810; RX; TABLETS
D-0493-2021
Recall number D-0493-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 12 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13608]
FDA event record
· Exact recall-number query on openFDA
drug · product 95 of 198
Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) 24x100 mL Single Dose Flexible Containers NDC 0143-9721-24 West-Ward Pharmaceutical Corp Eatontown, NJ 07724 USA
D-0494-2021
Recall number D-0494-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 35 bags
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information 2007046.1
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13323]
FDA event record
· Exact recall-number query on openFDA
drug · product 96 of 198
TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules; NDC/UPC 71858-0055-4; RX; CAPSULES
D-0495-2021
Recall number D-0495-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 25 boxes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15996]
FDA event record
· Exact recall-number query on openFDA
drug · product 97 of 198
Enbrace HR 30 ct. Softgels Enhanced Prenatal Vitamin Supplement Rx NDC 64661-650-30 Manufactured for: JAYMAC Pharmaceuticals, LLC, Sunset, LA 70584
D-0496-2021
Recall number D-0496-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 11 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16827]
FDA event record
· Exact recall-number query on openFDA
drug · product 98 of 198
Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain Reliever Fever Reducer 20 Liquid Gels 325 mg each NDC 50580-487-20
D-0497-2021
Recall number D-0497-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 37 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14336]
FDA event record
· Exact recall-number query on openFDA
drug · product 99 of 198
INVEGA SUSTENNA 156MG/1ML; NDC/UPC 50458056301; RX; SYRINGES
D-0498-2021
Recall number D-0498-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 534 syringes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13659]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0499-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 136 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16662]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0500-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 453 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16629]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0501-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 16 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13617]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0502-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 237 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13496]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0503-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 422 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13605]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0504-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 357 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13614]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0505-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 78 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13795]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0506-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 4 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information 20249489A
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13332]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0507-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 24 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16056]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0508-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 60 CARTON
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15357]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0509-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 33 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information BAD62005A
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17778]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0510-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 91 CARTON
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14772]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0511-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 71 tubes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13655]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0512-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 88 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16583]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0513-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 189 tubes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16065]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0514-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 380 BOTTLE
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13837]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0515-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 53 BOTTLE
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13738]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0516-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 19 BOTTLE
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13765]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0517-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 701 CARTON
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14380]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0518-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 37 BOTTLE
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16301]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0519-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 427 BOTTLE
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13805]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0520-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 407 BOXES
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15587]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0521-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 147
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13742]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0522-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 119 cartons
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13721]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0523-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 299 cartons
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15056]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0524-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 215 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17580]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0525-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 122 inhalers
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13309]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0526-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 112 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14094]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0527-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 72 cartons
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14761]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0528-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 620 injector
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14727]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0529-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 834 aerosol containers
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16997]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0530-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 47 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13750]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0531-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 523 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13753]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0532-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 205 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13362]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0533-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 28 tubes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13305]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0534-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 348 droptainers
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13620]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0535-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 341 CARTON
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16191]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0536-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 1189 cartons
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16371]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0537-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 60 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13657]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0538-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 131 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17468]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0539-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 55 Boxes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13360]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0540-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 236 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13665]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0541-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 39 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13739]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0542-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 5 tubes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14100]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0543-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 31 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14374]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0544-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 163 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13800]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0545-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 934 boxes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13827]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0546-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 321 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13831]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0547-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 2854 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13313]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0548-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 1371 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13373]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0549-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 180 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13769]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0550-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 95 suppositories
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16293]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0551-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 178 tubes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15756]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0552-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 49 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13365]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0553-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 341 vials
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information H074437AA
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14942]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0554-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 940 cartons
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16416]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0555-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 848 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[384]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0556-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 1040 cartons
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15892]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0557-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 13 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13746]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0558-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 49 CARTON
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13722]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0559-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 8 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13841]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0560-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 205 cartons
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13357]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0561-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 905 inhalers
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information 2000655C00
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17779]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0562-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 286 syringes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14253]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0563-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 148 syringes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13709]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0564-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 8 vials
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16808]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0565-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 143 tubes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13501]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0566-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 406 vials
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17573]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0567-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 1391 tubes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13499]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0568-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 223 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16895]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0569-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 133 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13622]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0570-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 490 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17083]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0571-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 160 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17425]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0572-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 2907 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15549]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0573-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 26895 inhalers
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13845]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0574-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 41 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13718]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0575-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 235 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16953]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0576-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 91 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information 35446365A
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17660]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0577-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 414 boxes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13328]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0578-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 1776 boxes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13770]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0579-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 23 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information 100016785
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15055]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0580-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 828 inhalers
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13733]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0581-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 57 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16753]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0582-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 92 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14512]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0583-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 52 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17099]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0584-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 37 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16810]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0585-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 80 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13781]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0586-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 86 BOTTLE
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13320]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0587-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 31 cartons
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13311]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0588-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 32 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13757]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0589-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 796 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13745]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0590-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 882 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17142]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0591-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 101 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17377]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0592-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 271 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16495]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0593-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 35 BOTTLE
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14353]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0594-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 2 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13741]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0595-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 6 boxes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[730]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0596-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 15 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13816]
FDA event record
· Exact recall-number query on openFDA
Recall number D-0597-2021
Initiated March 15, 2021
Classification Class II
Status Terminated
Quantity 10 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution pattern FL, GA, SC
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13788]
FDA event record
· Exact recall-number query on openFDA
