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Showing 661–680 of 1639 results

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Heparin Sodium Injection (Baxter) – Endotoxin Contamination (2024)

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

FDAAug 1, 2024Nationwide• Baxter Healthcare Corporation

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

Indomethacin Capsules (Glenmark) – Dissolution Specification Failure (2024)

Failed Dissolution Specifications: below specification results

Class IIModerate

FDAJul 31, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Progesterone Injection (Eugia US LLC) – Glass Particle Risk (2024)

Presence of Particulate Matter: Complaint received of a glass particle in the vial.

Class IIModerate

FDAJul 26, 2024Nationwide• Eugia US LLC

Sodium Chloride Injection (B. Braun) – Particulate Matter (2024)

Presence of Particulate Matter

FDAJul 24, 2024Nationwide• B. Braun Medical Inc

Ciprofloxacin Ophthalmic Solution (FDC) – Defective Container (2024)

Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

Class IIModerate

FDAJul 23, 2024Nationwide• FDC Limited

Azelaic Acid Gel (Glenmark) – CGMP Deviation (2024)

CGMP Deviations

Class IIModerate

FDAJul 22, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Timolol Maleate Solution (FDC) – Defective Container (2024)

Defective container; yellow colored spike from cap lodged in the nozzle

Class IIModerate

FDAJul 18, 2024Nationwide• FDC Limited

Gold Hard Steel Plus (Supercore) – Undeclared Drugs (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.

FDAJul 12, 2024Nationwide• Supercore Products Group Inc.

Hard Steel Capsules (Supercore) – Undeclared Drugs (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.

FDAJul 12, 2024Nationwide• Supercore Products Group Inc.

Acetaminophen (Aurobindo) – Missing Label (2024)

Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.

FDAJul 11, 2024NJ, NY, PA• Aurobindo Pharma USA Inc

Acetaminophen Injection (Hikma) – Label Mix-up (2024)

Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)

FDAJul 8, 2024OH, PR• Hikma Pharmaceuticals USA Inc.

Lidocaine HCL Injection (Tailstorm) – Subpotent Epinephrine (2024)

Subpotent Drug: reduced efficacy for epinephrine

Class IIModerate

FDAJul 3, 2024Nationwide• TAILSTORM HEALTH 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

Verapamil Hydrochloride 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

Decitabine Injection (Sun Pharma) – Microbial Count Issue (2024)

CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.

Class IIModerate

FDAJul 2, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Fludrocortisone Acetate Tablets (Teva) – Impurity Concerns (2024)

Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.

Class IIModerate

FDAJun 28, 2024Nationwide• Teva Pharmaceuticals USA, Inc

Pravastatin Sodium Tablets (Glenmark) – Dissolution Failure (2024)

Failed Dissolution Specifications: results below specifications

Class IIModerate

FDAJun 28, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

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