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Showing 21–40 of 14359 results

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Cinacalcet Tablets 90mg (Cipla) – Nitrosamine Impurity (2025)

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Class IIModerate

FDANov 14, 2025Nationwide• Cipla USA, Inc.

Ganirelix Acetate Injection (Lupin) – Impurity Specification (2025)

Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.

Class IIModerate

FDANov 13, 2025FL, MA, MI +1 more• Lupin Pharmaceuticals Inc.

Varenicline Tablets (Dr. Reddy's) – Subpotent Drug (2025)

Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

Class IIIModerate

FDANov 11, 2025Nationwide• Dr. Reddy's Laboratories, Inc.

Testosterone Gel 1% (Teva Pharmaceuticals) – leakage risk (2025)

Defective Container - A defect in the side-seal which allows leakage of product.

Class IIIModerate

FDANov 7, 2025Nationwide• Teva Pharmaceuticals USA, Inc

Famotidine Injection (Fresenius Kabi) – microbial contamination (2025)

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

Class IModerate

FDANov 6, 2025Nationwide• Fresenius Kabi USA, LLC

Sertraline Hydrochloride Tablets (Lupin) – defective container (2025)

Defective container - seal not adhering to bottles

Class IIModerate

FDANov 5, 2025Nationwide• Lupin Pharmaceuticals Inc.

Nivagen Zinc Oxide Ointment (Blossom) – cGMP deviation (2025)

cGMP deviations

Class IIModerate

FDAOct 31, 2025Nationwide• Blossom Pharmaceuticals

Phytonadione Injectable Emulsion (Cipla) – stability failure (2025)

Failed Stability Specifications: Observed OOS results: eg results for colour index

FDAOct 31, 2025Nationwide• Cipla Limited

Mepivacaine Injection (Novocol) – cracked cartridges (2025)

Defective container: cracked/broken cartridges

FDAOct 31, 2025Nationwide• Novocol Pharmaceutical of Canada, Inc.

Polocaine Dental (Novocol) – cracked cartridges (2025)

Defective container: cracked/broken cartridges

Class IIModerate

FDAOct 31, 2025Nationwide• Novocol Pharmaceutical of Canada, Inc.

Globe Zinc Oxide Ointment (Blossom) – cGMP deviation (2025)

cGMP deviations

Class IIModerate

FDAOct 31, 2025Nationwide• Blossom Pharmaceuticals

Globe Clotrimazole Cream (Blossom) – cGMP deviation (2025)

cGMP deviations

Class IIModerate

FDAOct 31, 2025Nationwide• Blossom Pharmaceuticals

2% Xylocaine DENTAL (Novocol) - Defective Container (2025)

Defective container: cracked/broken cartridges

Class IIModerate

FDAOct 31, 2025Nationwide• Novocol Pharmaceutical of Canada, Inc.

Nivagen Zinc Oxide Ointment (Blossom) – cGMP deviation (2025)

cGMP deviations

FDAOct 31, 2025Nationwide• Blossom Pharmaceuticals

Nivagen Zinc Oxide Ointment (Blossom) – cGMP deviation (2025)

cGMP deviations

Class IIModerate

FDAOct 31, 2025Nationwide• Blossom Pharmaceuticals

Lidocaine HCI with Epinephrine (Novocol) – cracked cartridges (2025)

Defective container: cracked/broken cartridges

FDAOct 31, 2025Nationwide• Novocol Pharmaceutical of Canada, Inc.

Mepivacaine Injection (Novocol) – cracked cartridges (2025)

Defective container: cracked/broken cartridges

Class IIModerate

FDAOct 31, 2025Nationwide• Novocol Pharmaceutical of Canada, Inc.

WeCare Zinc Oxide Ointment (Blossom) – cGMP deviation (2025)

cGMP deviations

FDAOct 31, 2025Nationwide• Blossom Pharmaceuticals

OraVerse Injection (Novocol) - Defective Container (2025)

Defective container: cracked/broken cartridges

Class IIModerate

FDAOct 31, 2025Nationwide• Novocol Pharmaceutical of Canada, Inc.

Globe Clotrimazole Cream (Blossom) - cGMP Deviations (2025)

cGMP deviations

FDAOct 31, 2025Nationwide• Blossom Pharmaceuticals

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