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Showing 121–140 of 216 results

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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

Micafungin Injection (Zydus Pharmaceuticals) – 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.

Class IIILow

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

Sevelamer Carbonate Suspension (Dr. Reddy's) – Labeling Error (2024)

Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets

FDAJun 26, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Hemp Bombs CBD Pain Freeze (Global Widget) – Menthol Subpotency (2024)

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

FDAJun 25, 2024Nationwide• GLOBAL WIDGET LLC

Nature's Script CBD Roll-On (Global Widget) – Menthol Subpotency (2024)

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

FDAJun 25, 2024Nationwide• GLOBAL WIDGET LLC

Hemp Bombs CBD Pain Freeze (Global Widget) – Menthol Subpotency (2024)

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

FDAJun 25, 2024Nationwide• GLOBAL WIDGET LLC

Hemp Bombs CBD Pain Freeze (Global Widget) – Menthol Subpotency (2024)

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

FDAJun 25, 2024Nationwide• GLOBAL WIDGET LLC

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.

T-MALE Testosterone Support (NaturesPlus) – ingredient mismatch (2024)

Product is missing the ingredient TongKat Ali and has additional Rhodiola Rosea

FDAMay 31, 2024Nationwide• Natural Organics, Inc.

Ultra T-MALE Testosterone Boost (NaturesPlus) – ingredient mismatch (2024)

Product is missing the ingredient TongKat Ali and has additional Rhodiola Rosea

FDAMay 31, 2024Nationwide• Natural Organics, Inc.

Asmanex Twisthaler (Organon) – Defective Container (2024)

Defective Container

FDAMay 28, 2024Nationwide• Organon Llc

Asmanex Twisthaler (Organon) – Defective Container (2024)

Defective Container

FDAMay 28, 2024Nationwide• Organon Llc

Asmanex Twisthaler (Organon) – Defective Container (2024)

Defective Container

FDAMay 28, 2024Nationwide• Organon Llc

Eptifibatide Injection (Eugia) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.

FDAMay 22, 2024Nationwide• Eugia US LLC

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