Recall events
/
Event 81810
Event summary
Timeline bucket December 17, 2018
Product types Drug
Classifications Class II
Statuses Terminated
Recalling firm wording Promise Pharmacy, LLC
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
51 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 51
Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.
D-0431-2019
Recall number D-0431-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 75 10 ml bottles
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lot: 11072018@10 BUD: 12/22/2018
Distribution pattern Nationwide in the USA.
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[10624]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 51
Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0432-2019
Recall number D-0432-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 43 3 mL bottles
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lot: 10252018@8 BUD: 2/10/2019
Distribution pattern Nationwide in the USA.
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[10153]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 51
Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0433-2019
Recall number D-0433-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 55 3 ml bottles
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lot: 11052018@4 BUD: 1/18/2019
Distribution pattern Nationwide in the USA.
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[10157]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 51
Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%, Combo Drops: 3 mL Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
D-0434-2019
Recall number D-0434-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 250 3 ml bottles
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 09262018@5 BUD: 1/15/2019; 10092018@1 BUD: 1/25/2019; 11052018@1 BUD: 2/21/2019
Distribution pattern Nationwide in the USA.
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[10876]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 51
Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 6 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
D-0435-2019
Recall number D-0435-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 2057 6 ml bottles
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 09192018@4 BUD: 12/18/2018; 10112018@1 BUD: 12/24/2018; 10262018@1 BUD: 1/8/2019; 10302018@1 BUD: 1/12/2019; 11082018@6 BUD: 1/21/2019
Distribution pattern Nationwide in the USA.
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[10392]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 51
Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
D-0436-2019
Recall number D-0436-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 900 3 ml bottles
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 11012018@1 BUD: 1/14/2019; 11022018@1 BUD: 1/15/2019
Distribution pattern Nationwide in the USA.
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[11005]
FDA event record
· Exact recall-number query on openFDA
drug · product 7 of 51
Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
D-0437-2019
Recall number D-0437-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 167 3 ml bottles
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 09262018@6 BUD: 12/25/2018; 11052018@2 BUD: 2/3/2019
Distribution pattern Nationwide in the USA.
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[10193]
FDA event record
· Exact recall-number query on openFDA
drug · product 8 of 51
Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2 mg/2.5 mg/25 mg/ 25 mg/ 2 mg/ 25 mg/mL 10 mL vial, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists, 31818 US Hwy 19N, Palm Harbor FL 34684
D-0438-2019
Recall number D-0438-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 204 10 ml vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 10092018@4 BUD: 1/7/2019; 11122018@7 BUD: 2/10/2019
Distribution pattern Nationwide in the USA.
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[10369]
FDA event record
· Exact recall-number query on openFDA
drug · product 9 of 51
Multi Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection 30 mL, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0439-2019
Recall number D-0439-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 3 30 ml vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lot: 10312018@5 BUD: 12/15/2018
Distribution pattern Nationwide in the USA.
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[10375]
FDA event record
· Exact recall-number query on openFDA
drug · product 10 of 51
Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0440-2019
Recall number D-0440-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 210 5 ml vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 09112018@10 BUD: 1/2/2019; 09212018@9 BUD: 1/12/2019; 11132018@10 BUD: 2/27/2019
Distribution pattern Nationwide in the USA.
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[10753]
FDA event record
· Exact recall-number query on openFDA
drug · product 11 of 51
Trim Complete, Methlonine/Inositol/Choline/Thiamine/Riboflavin/Niacinamide Dexpanthenol/Pyridoxine/Methylcobalamin/Leucine/Chromium 25 mg/50 mg/50 mg/25 mg/2.5 mg/25 mg/2 mg/25 mg/0.5 mg2.5 mg/1.33 mcg/mL injection 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0441-2019
Recall number D-0441-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 158 10 ml vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lot: 10022018@6 BUD: 12/31/2018
Distribution pattern Nationwide in the USA.
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[10724]
FDA event record
· Exact recall-number query on openFDA
drug · product 12 of 51
Methylcobalamin lyophilized 50,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0442-2019
Recall number D-0442-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 252 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 08212018@11 BUD: 12/19/2018; 10012018@1 BUD: 1/29/2019
Distribution pattern Nationwide in the USA.
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[11054]
FDA event record
· Exact recall-number query on openFDA
drug · product 13 of 51
Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0443-2019
Recall number D-0443-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 704 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 08032018@3 BUD: 01/30/2019; 08272018@6 BUD: 2/23/2019; 09142018@4 BUD: 3/13/2019; 10012018@3 BUD: 3/30/2019
Distribution pattern Nationwide in the USA.
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[10680]
FDA event record
· Exact recall-number query on openFDA
drug · product 14 of 51
Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/10 mg/mL 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0444-2019
Recall number D-0444-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 158 10 ml vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 08302018@12 BUD: 12/24/2018; 10242018@2 BUD: 2/17/2019
Distribution pattern Nationwide in the USA.
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[10861]
FDA event record
· Exact recall-number query on openFDA
drug · product 15 of 51
Glutathione Injection, 200 mg/mL, 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0445-2019
Recall number D-0445-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 288 10 ml vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 09172018@7 BUD: 12/16/2018; 10292018@2 BUD: 1/27/2019
Distribution pattern Nationwide in the USA.
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[10745]
FDA event record
· Exact recall-number query on openFDA
drug · product 16 of 51
Ascorbic Acid, Compounded-Tapioca, 450 mg/mL Injection, 50 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0446-2019
Recall number D-0446-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 196 50 ml vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 10152018@1 BUD: 1/13/2019; 10312018@2 BUD: 1/29/2019
Distribution pattern Nationwide in the USA.
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[10896]
FDA event record
· Exact recall-number query on openFDA
drug · product 17 of 51
Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0447-2019
Recall number D-0447-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 94 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 08302018@8 BUD: 2/26/2019; 10012018@2 BUD: 3/30/2019; 07052018@2 BUD: 01/01/2019
Distribution pattern Nationwide in the USA.
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[10606]
FDA event record
· Exact recall-number query on openFDA
drug · product 18 of 51
Sermorelin Theanine/GHRP2, 15 mg/75 mg/5.4 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0448-2019
Recall number D-0448-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 25 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lot: 07202018@4 BUD: 1/16/2019
Distribution pattern Nationwide in the USA.
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[10697]
FDA event record
· Exact recall-number query on openFDA
drug · product 19 of 51
Sermorelin 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0449-2019
Recall number D-0449-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 255 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 06182018@2 BUD: 12/15/2018; 08212018@12 BUD: 2/17/2019; 09212018@15 BUD: 3/20/2019; 11132018@1 BUD: 5/12/2019
Distribution pattern Nationwide in the USA.
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[10892]
FDA event record
· Exact recall-number query on openFDA
drug · product 20 of 51
Sermorelin/GHRP2/GHRP6, 9 mg/9 mg/9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0450-2019
Recall number D-0450-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 341 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 07102018@3 BUD: 1/6/2019 08302018@9 BUD: 2/26/2019
Distribution pattern Nationwide in the USA.
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[10889]
FDA event record
· Exact recall-number query on openFDA
drug · product 21 of 51
Sermorelin/GHRP2/GHRP6 6mg/3mg/3mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0451-2019
Recall number D-0451-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 296 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 08302018@13 BUD: 2/26/2019; 09212018@14 BUD: 3/20/2019
Distribution pattern Nationwide in the USA.
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[10216]
FDA event record
· Exact recall-number query on openFDA
drug · product 22 of 51
Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0452-2019
Recall number D-0452-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 927 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 07052018@1 BUD: 1/1/2019; 09182018@6 BUD: 3/1/2019; 09212018@10 BUD: 3/4/2019; 10052018@1 BUD: 3/18/2019; 11062018@2 BUD: 4/19/2019
Distribution pattern Nationwide in the USA.
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[10997]
FDA event record
· Exact recall-number query on openFDA
drug · product 23 of 51
Ipamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0453-2019
Recall number D-0453-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 416 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 07132018@5 BUD: 1/9/2019; 07302018@32 BUD: 1/26/2019; 09182018@7 BUD: 3/17/2019; 10192018@2 BUD: 4/17/2019
Distribution pattern Nationwide in the USA.
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[10378]
FDA event record
· Exact recall-number query on openFDA
drug · product 24 of 51
Ipamorelin+Sermorelin, 15mg/15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0454-2019
Recall number D-0454-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 139 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information 09212018@12 BUD: 12/20/2018; 11062018@3 BUD: 6/4/2019
Distribution pattern Nationwide in the USA.
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[10867]
FDA event record
· Exact recall-number query on openFDA
drug · product 25 of 51
Ipamorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0455-2019
Recall number D-0455-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 93 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 09182018@4 BUD: 3/17/2019; 10052018@3 BUD: 4/3/2019; 11132018@3 BUD: 5/12/2019
Distribution pattern Nationwide in the USA.
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[10638]
FDA event record
· Exact recall-number query on openFDA
drug · product 26 of 51
IGF-1 LR3, 620 mcg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0456-2019
Recall number D-0456-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 59 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lot: 06282018@3 BUD: 12/25/2018
Distribution pattern Nationwide in the USA.
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[11057]
FDA event record
· Exact recall-number query on openFDA
drug · product 27 of 51
Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0457-2019
Recall number D-0457-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 30 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 09212018@11 BUD: 12/20/2018; 11132018@4 BUD: 2/11/2019
Distribution pattern Nationwide in the USA.
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[10380]
FDA event record
· Exact recall-number query on openFDA
drug · product 28 of 51
Bremelanotide (PT 141), 20mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0458-2019
Recall number D-0458-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 64 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 10192018@4 BUD: 12/18/2019; 11132018@5 BUD: 1/12/2019
Distribution pattern Nationwide in the USA.
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[10665]
FDA event record
· Exact recall-number query on openFDA
drug · product 29 of 51
BPC 157, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0459-2019
Recall number D-0459-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 37 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lot: 11062018@5 BUD: 2/4/2019
Distribution pattern Nationwide in the USA.
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[10843]
FDA event record
· Exact recall-number query on openFDA
drug · product 30 of 51
HCG, Human chorionic gonadotropin 11,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0460-2019
Recall number D-0460-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 654 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 06182018@5 BUD: 12/15/2018; 07102018@5 BUD: 1/6/2018; 08212018@8 BUD: 2/17/2019
Distribution pattern Nationwide in the USA.
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[10898]
FDA event record
· Exact recall-number query on openFDA
drug · product 31 of 51
HCG, Human chorionic gonadotropin 5,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0461-2019
Recall number D-0461-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 2595 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 06252018@1 BUD: 12/22/2018; 07132018@7 BUD: 1/9/2019; 07262018@2 BUD: 1/22/2019; 08212018@7 BUD: 2/17/2019; 08272018@2 BUD: 2/23/2019; 09052018@2 BUD: 2/28/2019
Distribution pattern Nationwide in the USA.
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[10675]
FDA event record
· Exact recall-number query on openFDA
drug · product 32 of 51
HCG, Human chorionic gonadotropin 2,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0462-2019
Recall number D-0462-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 819 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 07172018@15 BUD: 1/13/2019; 08272018@3 BUD: 2/23/2019
Distribution pattern Nationwide in the USA.
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[11026]
FDA event record
· Exact recall-number query on openFDA
drug · product 33 of 51
Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0463-2019
Recall number D-0463-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 266 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 07102018@4 BUD: 1/6/2019; 09142018@6 BUD: 3/13/2019; 10052018@4 BUD: 4/3/2019; 11062018@1 BUD: 5/5/2019
Distribution pattern Nationwide in the USA.
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[10196]
FDA event record
· Exact recall-number query on openFDA
drug · product 34 of 51
IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0464-2019
Recall number D-0464-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 59 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lot: 06282018@2 BUD: 12/25/2018
Distribution pattern Nationwide in the USA.
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[10139]
FDA event record
· Exact recall-number query on openFDA
drug · product 35 of 51
Melanotan II, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0465-2019
Recall number D-0465-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 43 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 07202018@3 BUD: 1/13/2019; 09212018@13 BUD: 2/28/2019
Distribution pattern Nationwide in the USA.
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[10715]
FDA event record
· Exact recall-number query on openFDA
drug · product 36 of 51
ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/Chromium/Lidocaine: 25mg/25mg/5mg/2.5mg/25mg/5mg/5mg/0.1mg/1.5mg/25mg/25mg/10mg/ML, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0466-2019
Recall number D-0466-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 846 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 09262018@1 BUD: 12/25/2018; 10232018@5 BUD: 1/21/2019; 11012018@3 BUD: 1/30/2019
Distribution pattern Nationwide in the USA.
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[10136]
FDA event record
· Exact recall-number query on openFDA
drug · product 37 of 51
MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcobalamin+L-Carnitine+Chromium, 25mg/50mg/50mg/1mg/100mg/0.4mcg/ml, 10mL, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0467-2019
Recall number D-0467-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 64 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lot: 10102018@1 BUD: 1/8/2019
Distribution pattern Nationwide in the USA.
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[10868]
FDA event record
· Exact recall-number query on openFDA
drug · product 38 of 51
Nicotinamide Adenine Dinucleotide, 0.5 mg, injection, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0468-2019
Recall number D-0468-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 5 10 mL vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 11062018@13 BUD: 12/21/2018; 11072018@24 BUD: 12/22/2018
Distribution pattern Nationwide in the USA.
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[10669]
FDA event record
· Exact recall-number query on openFDA
drug · product 39 of 51
Niacinamide injection, 100mg/mL, 5mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0469-2019
Recall number D-0469-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 1 vial
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lot: 11022018@9 BUD: 12/17/2018
Distribution pattern Nationwide in the USA.
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[10683]
FDA event record
· Exact recall-number query on openFDA
drug · product 40 of 51
Myer's Cocktail, Pyridoxine/Dexpanthenol/Calcium Gluconate/Niacinamide/Vit B6/Vit B1/Leucine/Vit B5/Riboflavin/Ascorbic Acid/Hydroxycobalamin/Magnesium Chloride, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0470-2019
Recall number D-0470-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 5 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lot: 11072018@2 BUD: 12/14/2018
Distribution pattern Nationwide in the USA.
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[10156]
FDA event record
· Exact recall-number query on openFDA
drug · product 41 of 51
Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0471-2019
Recall number D-0471-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 2 10 ml vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 11132018@9 BUD: 12/28/2018;
Distribution pattern Nationwide in the USA.
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[10191]
FDA event record
· Exact recall-number query on openFDA
drug · product 42 of 51
Folic Acid, Injection, 10 mg/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0472-2019
Recall number D-0472-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 5 10ml vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 11022018@4 BUD: 12/17/2018;
Distribution pattern Nationwide in the USA.
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[11016]
FDA event record
· Exact recall-number query on openFDA
drug · product 43 of 51
Trim Calm, GABA/Magnesium/Taurine/Theanine, 50mg/50mg/50mg/50mg/ml, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0473-2019
Recall number D-0473-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 7 10 ml vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lot: 11052018@7 BUD: 12/20/2018
Distribution pattern Nationwide in the USA.
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[10664]
FDA event record
· Exact recall-number query on openFDA
drug · product 44 of 51
Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0474-2019
Recall number D-0474-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 11 10ml vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lots: 11082018@4 BUD: 12/23/2018; 10302018@4 BUD: 12/14/2018
Distribution pattern Nationwide in the USA.
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[10902]
FDA event record
· Exact recall-number query on openFDA
drug · product 45 of 51
Pyridoxine HCl, 100 mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0475-2019
Recall number D-0475-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 8 10ml vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lot: 10302018@3 BUD: 12/14/2018
Distribution pattern Nationwide in the USA.
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[10647]
FDA event record
· Exact recall-number query on openFDA
drug · product 46 of 51
Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0476-2019
Recall number D-0476-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 15 10ml vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lot: 10312018@3 BUD: 12/15/2018
Distribution pattern Nationwide in the USA.
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[10685]
FDA event record
· Exact recall-number query on openFDA
drug · product 47 of 51
Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0477-2019
Recall number D-0477-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 11 10 ml vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lot: 11132018@8 BUD: 12/28/2018
Distribution pattern Nationwide in the USA.
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[10372]
FDA event record
· Exact recall-number query on openFDA
drug · product 48 of 51
Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0478-2019
Recall number D-0478-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 7 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lot: 11052018@5 BUD: 12/20/2018
Distribution pattern Nationwide in the USA.
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[10651]
FDA event record
· Exact recall-number query on openFDA
drug · product 49 of 51
Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0479-2019
Recall number D-0479-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 2 10ml vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lot: 11052018@6 BUD: 12/20/2018
Distribution pattern Nationwide in the USA.
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[10363]
FDA event record
· Exact recall-number query on openFDA
drug · product 50 of 51
Zinc Sulfate,10mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0480-2019
Recall number D-0480-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 3
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lot: 10302018@7, BUD 12/14/2018
Distribution pattern Nationwide in the USA.
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[10132]
FDA event record
· Exact recall-number query on openFDA
drug · product 51 of 51
Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0481-2019
Recall number D-0481-2019
Initiated December 17, 2018
Classification Class II
Status Terminated
Quantity 1 10 ml vial
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of sterility assurance.
Code information Lot: 10302018@8, BUD 12/14/2018
Distribution pattern Nationwide in the USA.
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[10623]
FDA event record
· Exact recall-number query on openFDA
