Recall events
/
Event 64188
Event summary
Timeline bucket January 30, 2013
Product types Drug
Classifications Class II
Statuses Terminated
Recalling firm wording TG United, 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
44 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 44
AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 4 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-04
D-503-2013
Recall number D-503-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 1398 - 4 ounce 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot # 12HQ002 Exp. 07/14.
Distribution pattern FL, MS, SC, LA and TX
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[5563]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 44
AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-16
D-504-2013
Recall number D-504-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 348 - 16 ounce 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot # 12DQ002, Exp. 03/14.
Distribution pattern FL, MS, SC, LA and TX
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[8111]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 44
AMBI 25DPH/7.5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0226-16
D-505-2013
Recall number D-505-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 352 - 16 ounce 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot # 12DQ005, Exp. 03/14.
Distribution pattern FL, MS, SC, LA and TX
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[5747]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 44
AMBI 12.5 CPD/100GFN/30PSE, Antitussive, Expectorant, Nasal Decongestant, Raspberry Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0223-16
D-506-2013
Recall number D-506-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 348 - 16 ounce 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot # 12HQ005, Exp. 07/14.
Distribution pattern FL, MS, SC, LA and TX
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[7198]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 44
AMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant, Expectorant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0224-16
D-507-2013
Recall number D-507-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 348 - 16 ounce 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot # 12HQ006, Exp. 07/14.
Distribution pattern FL, MS, SC, LA and TX
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[5701]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 44
AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0221-16.
D-508-2013
Recall number D-508-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 348 - 16 ounce 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot # 12HQ007 Exp. 07/14.
Distribution pattern FL, MS, SC, LA and TX
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[5713]
FDA event record
· Exact recall-number query on openFDA
drug · product 7 of 44
AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.
D-509-2013
Recall number D-509-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 355 - 16 ounce 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot # 12DQ004, Exp. 03/14.
Distribution pattern FL, MS, SC, LA and TX
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[5684]
FDA event record
· Exact recall-number query on openFDA
drug · product 8 of 44
AMBI 3BRM/15DM/30PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0230-16.
D-510-2013
Recall number D-510-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 348 - 16 ounce 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot # 12HQ003, Exp. 07/14.
Distribution pattern FL, MS, SC, LA and TX
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[7804]
FDA event record
· Exact recall-number query on openFDA
drug · product 9 of 44
AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0229-16
D-511-2013
Recall number D-511-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 348 - 16 ounce 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot # 12HQ004, Exp. 07/14.
Distribution pattern FL, MS, SC, LA and TX
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[7814]
FDA event record
· Exact recall-number query on openFDA
drug · product 10 of 44
AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01
D-512-2013
Recall number D-512-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 1772 bottles per 100 count each
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: Products are underdosed or have an incorrect dosage regime.
Code information Lot # 11D001 Exp. 03/13; Lot # 11D002 Exp. 03/13; Lot#11K003 Exp. 09/13; Lot# 12C010 Exp. 02/14.
Distribution pattern FL, MS, SC, LA and TX
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[5757]
FDA event record
· Exact recall-number query on openFDA
drug · product 11 of 44
AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01
D-513-2013
Recall number D-513-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 886 bottles - 100-count tablets
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: Products are underdosed or have an incorrect dosage regime.
Code information Lot # 12C007 Exp. 02/14; Lot # 12C008 Exp. 02/14.
Distribution pattern FL, MS, SC, LA and TX
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[7242]
FDA event record
· Exact recall-number query on openFDA
drug · product 12 of 44
Ryddex G Tablets, Decongestant, Expectorant, 100 count bottle, OTC, Centurion Labs, LLC 657 Hwy 40 South, Ste B, Richland, MS 39218, NDC 23359-024-10
D-514-2013
Recall number D-514-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 2957 bottles 100-count tablets
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: Products are underdosed or have an incorrect dosage regime.
Code information Lot # 11E002 Exp. 04/2013.
Distribution pattern FL, MS, SC, LA and TX
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[5744]
FDA event record
· Exact recall-number query on openFDA
drug · product 13 of 44
ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01
D-515-2013
Recall number D-515-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 242,470
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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11L008 Exp. 10/13; Lot# 12A001 Exp. 12/13; Lot# 12A002 Exp. 12/13; Lot# 12A006 Exp. 12/13; Lot#12A006 Exp. 12/13; Lot# 12A007 Exp. 12/13; Lot#12D013 Exp. 03/14; Lot# 12F002 Exp. 05/14; Lot# 12H006 Exp.07/14; Lot# 12J001 Exp. 08/14; Lot# 12J001 Exp. 08/14; Lot# 12K005 Exp. 09/14; Lot #12M002 Exp. 11/14; Lot# 12M003 Exp. 11/14.
Distribution pattern FL, MS, SC, LA and TX
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[7791]
FDA event record
· Exact recall-number query on openFDA
drug · product 14 of 44
NoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Distributed by: Larken Laboratories, Inc., Canton, MS 39046, NDC 68047-173-01
D-516-2013
Recall number D-516-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 4824 bottles - 100-count
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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11K010 Exp. 09/13.
Distribution pattern FL, MS, SC, LA and TX
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[5579]
FDA event record
· Exact recall-number query on openFDA
drug · product 15 of 44
Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-160-01
D-517-2013
Recall number D-517-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 31,739 bottles 100-count; 842,617 Bulk tablet 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11L006 Exp. 10/13; Lot# 11L006 Exp. 10/13; Lot# 12B003 Exp 01/14; Lot# 12B003 Exp. 01/14; Lot#12D005 Exp. 03/14; Lot# 12D005 Exp. 03/14; Lot# 12H001 Exp. 07/14.
Distribution pattern FL, MS, SC, LA and TX
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[5647]
FDA event record
· Exact recall-number query on openFDA
drug · product 16 of 44
Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-152-01
D-518-2013
Recall number D-518-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 8296 bottles - 100-count and 153,028 Bulk tablets
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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 12B001 Exp. 01/14; Lot# 12B001 Exp. 01/14; Lot# 12B002 Exp 01/14; Lot# 12F013 Exp. 05/2014; Lot# 12F013 Exp. 05/2014.
Distribution pattern FL, MS, SC, LA and TX
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[7821]
FDA event record
· Exact recall-number query on openFDA
drug · product 17 of 44
BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16
D-519-2013
Recall number D-519-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 22,721 - 16 ounce 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 12B001 Exp. 01/14; Lot# 12B001 Exp. 01/14; Lot# 12B002 Exp 01/14; Lot# 12F013 Exp. 05/14; Lot# 12F013 Exp. 05/14.
Distribution pattern FL, MS, SC, LA and TX
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[8089]
FDA event record
· Exact recall-number query on openFDA
drug · product 18 of 44
Cardec Drops,Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-604-30
D-520-2013
Recall number D-520-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 26,536 bottles - 30 mL
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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11DQ009 Exp. 03/13; Lot# 11JQ002 Exp. 08/13.
Distribution pattern FL, MS, SC, LA and TX
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[5584]
FDA event record
· Exact recall-number query on openFDA
drug · product 19 of 44
Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-550-30
D-521-2013
Recall number D-521-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 216,838 bottles - 30 mL
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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11CQ001 Exp. 02/13; Lot# 11CQ009 Exp. 02/13; Lot # 11JQ003 Exp. 08/13; Lot# 11JQ004 Exp. 08/23; Lot# 11MQ002 Exp. 11/13.
Distribution pattern FL, MS, SC, LA and TX
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[7782]
FDA event record
· Exact recall-number query on openFDA
drug · product 20 of 44
Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01
D-522-2013
Recall number D-522-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 2706 bottles of 100 count tablets
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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11B002 Exp. 01/13; Lot# 11B003 Exp. 01/13; Lot # 11G007 Exp. 06/13; Lot# 11J002 Exp. 08/13; Lot# 11K002 Exp. 09/13; Lot# 12C011 Exp. 02/14.
Distribution pattern FL, MS, SC, LA and TX
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[7811]
FDA event record
· Exact recall-number query on openFDA
drug · product 21 of 44
Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. Brooksville, FL 34604, NDC 58605-0408-01
D-523-2013
Recall number D-523-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 1623 bottles of 100-count tablets.
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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11G006 Exp. 06/13; Lot# 11K001 Exp. 09/13; Lot # 11K001 Exp. 09/13; Lot# 12C009 Exp. 02/14.
Distribution pattern FL, MS, SC, LA and TX
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[5717]
FDA event record
· Exact recall-number query on openFDA
drug · product 22 of 44
BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01
D-524-2013
Recall number D-524-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 10,036 bottles - 100-count tablets
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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11A001 Exp. 12/12; Lot# 11L002 Exp. 10/13; Lot # 12K007 Exp. 09/14.
Distribution pattern FL, MS, SC, LA and TX
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[8104]
FDA event record
· Exact recall-number query on openFDA
drug · product 23 of 44
BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01
D-525-2013
Recall number D-525-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 16,836 bottles - 100-count.
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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11A002 Exp. 12/12; Lot# 11A003 Exp. 12/12; Lot # 11A004 Exp. 12/12; Lot# 11A005 Exp. 12/12; Lot# 11L003 Exp. 10/13.
Distribution pattern FL, MS, SC, LA and TX
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[5728]
FDA event record
· Exact recall-number query on openFDA
drug · product 24 of 44
BroveX PSB LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-150-01 b) 20 ml NDC 58605-150-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737
D-526-2013
Recall number D-526-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 57,936 bottles - 20 mL and 7,476 bottles -16 ounce
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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11CQ005 Exp. 02/13; Lot# 11LQ002 Exp. 10/13; Lot # 12CQ005-Exp. 02/14; Lot# 12EQ003 Exp. 04/14; Lot# 12EQ004 Exp. 04/14; Lot# 12JQ004 Exp. 08/14.
Distribution pattern FL, MS, SC, LA and TX
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[8117]
FDA event record
· Exact recall-number query on openFDA
drug · product 25 of 44
BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-151-01 b) 20 ml NDC 58605-151-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737
D-527-2013
Recall number D-527-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 19,728 bottles - 20 mL and 20,016 bottles - 16 ounce.
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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11AQ004 Exp. 12/12; Lot# 11AQ005 Exp. 12/12; Lot # 11AQ006 Exp. 12/12; Lot# 11AQ007 Exp. 12/12; Lot # 11BQ012 Exp. 01/13; Lot# 11LQ003 Exp. 10/13; Lot# 11LQ004 Exp. 10/13; Lot# 11LQ005 Exp 10/13; Lot# 11LQ006 Exp. 10/2013.
Distribution pattern FL, MS, SC, LA and TX
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[5741]
FDA event record
· Exact recall-number query on openFDA
drug · product 26 of 44
Lusair Liquid, 1 PINT bottle, OTC, Marketed by: Pernix Therapeutics, Gonzales, LA 70737 NDC 23359-017-16
D-528-2013
Recall number D-528-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity N/A
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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11AQ004 Exp. 12/12; Lot# 11AQ005 Exp. 12/12; Lot # 11AQ006 Exp. 12/12; Lot# 11AQ007 Exp. 12/12; Lot # 11BQ012 - 19728 20 mL, Exp. 01/13; Lot# 11LQ003 Exp. 10/13; Lot# 11LQ004 Exp. 10/13; Lot# 11LQ005 Exp 10/13; Lot# 11LQ006 Exp. 10/13.
Distribution pattern FL, MS, SC, LA and TX
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[7826]
FDA event record
· Exact recall-number query on openFDA
drug · product 27 of 44
Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-210-01
D-529-2013
Recall number D-529-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 330158 Bulk tablets.
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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 12L005 Exp 10/14.
Distribution pattern FL, MS, SC, LA and TX
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[7186]
FDA event record
· Exact recall-number query on openFDA
drug · product 28 of 44
Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-309-60
D-530-2013
Recall number D-530-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 977,719 Bulk Tablets
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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11F005 Exp 05/13; Lot# 11M008 Exp 11/13; Lot# 12J003 Exp 08/12.
Distribution pattern FL, MS, SC, LA and TX
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[5737]
FDA event record
· Exact recall-number query on openFDA
drug · product 29 of 44
Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355, NDC 50991-561-60
D-531-2013
Recall number D-531-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 978,092 Bulk Tablets
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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11F003 Exp 05/13; Lot# 11M007 Exp 11/13; Lot# 12J002 Exp 08/14.
Distribution pattern FL, MS, SC, LA and TX
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[5644]
FDA event record
· Exact recall-number query on openFDA
drug · product 30 of 44
TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, Inc. Brooksville, FL 34604 NDC 29273-0706-10
D-532-2013
Recall number D-532-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 386 - 1000-count 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11A006 Exp 12/12; Lot# 11A007 Exp 12/12; Lot# 11G004 Exp 06/14; Lot# 11G005 Exp 06/14; Lot# 12C004 Exp 02/14; Lot# 12F007 Exp 05/14; Lot# 12F008 Exp.05/14; Lot #12F009 Exp. 05/14; Lot# 12G005 Exp 06/14.
Distribution pattern FL, MS, SC, LA and TX
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[5749]
FDA event record
· Exact recall-number query on openFDA
drug · product 31 of 44
CPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-071-30
D-533-2013
Recall number D-533-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 6551 30 mL 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11GQ003 Exp 06/13.
Distribution pattern FL, MS, SC, LA and TX
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[8097]
FDA event record
· Exact recall-number query on openFDA
drug · product 32 of 44
CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-072-30
D-534-2013
Recall number D-534-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 26,315 - 30 mL 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11EQ007 Exp 04/13; Lot# 12BQ001 Exp. 01/14..
Distribution pattern FL, MS, SC, LA and TX
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[5556]
FDA event record
· Exact recall-number query on openFDA
drug · product 33 of 44
Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0085-16
D-535-2013
Recall number D-535-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 12,120 - 16 ounce 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11CQ010 Exp 02/13; Lot# 11EQ003 Exp. 04/13; Lot# 11FQ002 Exp. 05/13; Lot# 11FQ003 Exp. 05/13; Lot# 12HQ009 Exp. 07/14.
Distribution pattern FL, MS, SC, LA and TX
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[5560]
FDA event record
· Exact recall-number query on openFDA
drug · product 34 of 44
Mesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0075-16
D-536-2013
Recall number D-536-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 4,884 - 16 ounce 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11DQ001 Exp 03/13; Lot# 11MQ010 Exp. 11/13.
Distribution pattern FL, MS, SC, LA and TX
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[5649]
FDA event record
· Exact recall-number query on openFDA
drug · product 35 of 44
TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-067-16
D-537-2013
Recall number D-537-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 2532 - 16 ounce 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11AQ003 Exp 12/12.
Distribution pattern FL, MS, SC, LA and TX
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[5723]
FDA event record
· Exact recall-number query on openFDA
drug · product 36 of 44
TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-068-16
D-538-2013
Recall number D-538-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 98,202 16 ounce 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11CQ011 Exp 02/13; Lot# 11DQ007 Exp. 03/13; Lot# 11DQ008 Exp. 03/13; Lot# 11EQ002 Exp. 04/13; Lot # 11KQ004 Exp 09/13; Lot# 11KQ005 Exp. 09/13
Distribution pattern FL, MS, SC, LA and TX
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[8122]
FDA event record
· Exact recall-number query on openFDA
drug · product 37 of 44
TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-083-30
D-539-2013
Recall number D-539-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 13,031 30 mL 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 12GQ003 Exp 06/14.
Distribution pattern FL, MS, SC, LA and TX
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[5714]
FDA event record
· Exact recall-number query on openFDA
drug · product 38 of 44
Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-088-16
D-540-2013
Recall number D-540-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 12,198 - 16 ounce 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11FQ004 Exp 05/13; Lot# 11KQ001 Exp. 09/13; Lot# 11KQ002 Exp. 09/13; Lot#11KQ003 Exp. 09/13; Lot# 12HQ010 Exp. 07/14.
Distribution pattern FL, MS, SC, LA and TX
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[5753]
FDA event record
· Exact recall-number query on openFDA
drug · product 39 of 44
Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ, 08872, NDC 13811-0081-30
D-541-2013
Recall number D-541-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 39,403 - 30 mL 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11EQ010 Exp 04/13; Lot# 12AQ001 Exp. 12/13; Lot# 12JQ006 Exp. 08/14.
Distribution pattern FL, MS, SC, LA and TX
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[7218]
FDA event record
· Exact recall-number query on openFDA
drug · product 40 of 44
Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0082-30
D-542-2013
Recall number D-542-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 40,149 - 30 mL 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11EQ008 Exp 04/13; Lot# 11HQ003 Exp. 07/13; Lot# 12JQ007 Exp. 08/14.
Distribution pattern FL, MS, SC, LA and TX
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[8110]
FDA event record
· Exact recall-number query on openFDA
drug · product 41 of 44
Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0001-30
D-543-2013
Recall number D-543-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 12,988 - 30 mL 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11DQ004 Exp 03/13.
Distribution pattern FL, MS, SC, LA and TX
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[5693]
FDA event record
· Exact recall-number query on openFDA
drug · product 42 of 44
Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0002-16
D-544-2013
Recall number D-544-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 2388 - 16 ounce 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11EQ004 Exp 04/13.
Distribution pattern FL, MS, SC, LA and TX
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[8120]
FDA event record
· Exact recall-number query on openFDA
drug · product 43 of 44
ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0080-30
D-545-2013
Recall number D-545-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 39,801 - 30 mL 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11EQ009 Exp 04/13; Lot# 12AQ004 Exp. 12/13; Lot# 12KQ001 Exp. 09/14.
Distribution pattern FL, MS, SC, LA and TX
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[5720]
FDA event record
· Exact recall-number query on openFDA
drug · product 44 of 44
ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0073-16
D-546-2013
Recall number D-546-2013
Initiated January 30, 2013
Classification Class II
Status Terminated
Quantity 4811 - 16 ounce 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: Products are underdosed or have an incorrect dosage regime.
Code information Lot# 11CQ012 Exp 02/13; Lot# 12GQ002 Exp. 06/14.
Distribution pattern FL, MS, SC, LA and TX
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[5724]
FDA event record
· Exact recall-number query on openFDA
