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Showing 61–80 of 133 results

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Diphenhydramine HCl 25mg 100ct (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Acetaminophen Extra Strength 500mg 1000ct (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Acetaminophen Regular Strength (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Class IIILow

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Acetaminophen Tablets (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Diphenhydramine HCl 25mg (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Javygtor Tablets 100mg (Dr. Reddy's) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications

FDANov 22, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Esomeprazole Oral Suspension (Zydus) – Incorrect NDC Number (2024)

Labeling: Not Elsewhere Classified - Wrong NDC number

FDANov 14, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

IBU Tablets (Dr. Reddy's) – Failed Specifications (2024)

Failed Tablet/Capsule Specifications

FDAOct 29, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Ciclopirox Gel (Glenmark) – Broken Tube Seal (2024)

Defective Container: Firm received complaints of broken tube at the seal.

FDASep 30, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

AcetaZOLAMIDE Tablets (Rubicon) – Discoloration (2024)

Discoloration

FDAAug 24, 2024Nationwide• Rubicon Research Private Limited

Methotrexate Tablets (Amneal) – Foreign Tablet Contamination (2024)

Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.

FDAAug 1, 2024Nationwide• Amneal Pharmaceuticals, LLC

Verapamil Hydrochloride Injection (Zydus) – Cross Contamination (2024)

Cross contamination with other products.

FDAJul 2, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Verapamil Hydrochloride Injection (Zydus) – Cross Contamination (2024)

Cross contamination with other products.

FDAJul 2, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Micafungin Injection (Zydus) – Cross Contamination (2024)

Cross contamination with other products

FDAJul 2, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Micafungin Injection (Zydus Pharmaceuticals) – Cross Contamination (2024)

Cross contamination with other products

FDAJul 2, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Diflorasone Diacetate Ointment (Rising Pharma) – Impurity Concerns (2024)

Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.

FDAJun 24, 2024Nationwide• Rising Pharma Holding, Inc.

SinuFrin Nasal Decongestant (Neilmed) – Sub-Potent Drug (2024)

Sub-potent Drug

FDAJun 24, 2024Nationwide• Neilmed Pharmaceuticals Inc

Dodex Injectable (Accord Healthcare) – Subpotent Drug (2024)

Subpotent drug: out of specification results

FDAJun 18, 2024Nationwide• Accord Healthcare, Inc.

Eszopiclone Tablets (Dr. Reddy's) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications: Related Substances

FDAJun 4, 2024MS, OH• Dr. Reddy's Laboratories, Inc.

Asmanex Twisthaler (Organon) – Defective Container (2024)

Defective Container

FDAMay 28, 2024Nationwide• Organon Llc

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