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Showing 461–480 of 14362 results

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Pravastatin Sodium Tablets (Glenmark) – CGMP Deviations (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

ChlorproMAZINE Tablets 100mg (Glenmark) – CGMP Deviations (2025)

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.

Class IIModerate

FDAMar 11, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Ciprofloxacin Ophthalmic Solution (FDC) – Defective Container (2025)

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

FDAMar 11, 2025Nationwide• FDC Limited

Omni-Macs Dietary Supplement (Veridance) – Excessive Iodine (2025)

Levels of iodine exceeding label claim

Class IIModerate

FDAMar 10, 2025IN, MO• Veridance Pharmacal, LLC

Cinacalcet Hydrochloride Tablets (Slate Run Pharmaceuticals) – Nitrosamine Impurity (2025)

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

Class IIModerate

FDAMar 7, 2025Nationwide• Slate Run Pharmaceuticals

Levothyroxine Sodium Tablets (Mylan) – Super-Potent Drug (2025)

Super-Potent Drug: Out of specification potency results were obtained.

Class IIModerate

FDAMar 7, 2025Nationwide• Mylan Institutional, Inc.

Duloxetine D/R (Direct Rx) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Class IIModerate

FDAMar 7, 2025Nationwide• Direct Rx

Cinacalcet Hydrochloride Tablets (Slate Run Pharmaceuticals) – Nitrosamine Impurity (2025)

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

Class IIModerate

FDAMar 7, 2025Nationwide• Slate Run Pharmaceuticals

Sofosbuvir and Velpatasvir (ASEGUA) – Defective Container (2025)

Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.

Class IIModerate

FDAMar 7, 2025Nationwide• ASEGUA THERAPEUTICS LLC

Duloxetine D/R (Direct Rx) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Class IIModerate

FDAMar 7, 2025Nationwide• Direct Rx

Sodium Bicarbonate Injection (Exela Pharma) – Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 7, 2025Nationwide• Exela Pharma Sciences LLC

Levothyroxine Sodium Tablets (Mylan) – Super-Potent Drug (2025)

Super-Potent Drug: Out of specification potency results were obtained.

Class IIModerate

FDAMar 7, 2025Nationwide• Mylan Institutional, Inc.

Fentanyl Citrate (QuVa Pharma) – Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 6, 2025Nationwide• QuVa Pharma, Inc.

Fentanyl Citrate (QuVa Pharma) – Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 6, 2025Nationwide• QuVa Pharma, Inc.

Fentanyl Citrate (QuVa Pharma) – Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 6, 2025Nationwide• QuVa Pharma, Inc.

Duloxetine Capsules (Rising Pharma) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Class IIModerate

FDAMar 5, 2025Nationwide• Rising Pharma Holding, Inc.

Testosterone Gel (Strides Pharma) – Benzene Presence (2025)

Presence of foreign substance: Presence of Benzene.

Class IIModerate

FDAMar 5, 2025Nationwide• Strides Pharma, Inc.

Prasugrel Tablets (Golden State Medical) – Dissolution Failure (2025)

Failed Dissolution Specifications

Class IIModerate

FDAMar 5, 2025Nationwide• Golden State Medical Supply Inc.

Testosterone Gel (Strides Pharma) – Benzene Presence (2025)

Presence of foreign substance: Presence of Benzene.

Class IIModerate

FDAMar 5, 2025Nationwide• Strides Pharma, Inc.

Gabapentin Capsules (Sun Pharmaceutical) – Cross Contamination (2025)

Cross Contamination

Class IIILow

FDAMar 4, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

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