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Showing 221–240 of 505 results

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Carvedilol Tablets 25mg (Glenmark) - Nitrosamine Excess (2025)

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Class IIModerate

FDAAug 6, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Metoprolol Tablets 50mg (Westminster) - Nitrosamine Risk (2025)

CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

Class IIModerate

FDAAug 6, 2025Nationwide• Westminster Pharmaceuticals LLC

Metoprolol Tablets 100mg (Westminster) - Nitrosamine Risk (2025)

CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

Class IIModerate

FDAAug 6, 2025Nationwide• Westminster Pharmaceuticals LLC

Enoxaparin Sodium Injection (Cardinal Health) - Product Mispack (2025)

Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL

Class IIModerate

FDAAug 5, 2025KS• Cardinal Health Inc.

Baby Bedtime Drops (M.O.M Enterprises) – Yeast Contamination (2025)

Potential for spoilage due to yeast contamination.

Class IIModerate

FDAAug 5, 2025AL, AZ, AR +28 more• M.O.M Enterprises, LLC.

Spironolactone Tablets (Sun Pharma) - Foreign Substance (2025)

Presence of foreign substance: identified as aluminum.

Class IIModerate

FDAAug 5, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Sodium Bicarbonate Injection (Pfizer) - Sterility Issue (2025)

Lack of Assurance of Sterility.

Class IIModerate

FDAAug 4, 2025Nationwide• PFIZER INC

Sodium Chloride Injection (B Braun) - Sterility Concern (2025)

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

Class IIModerate

FDAAug 4, 2025Nationwide• B BRAUN MEDICAL INC

Epinephrine Injection (Pfizer) - Sterility Issue (2025)

Lack of Assurance of Sterility.

Class IIModerate

FDAAug 4, 2025Nationwide• PFIZER INC

Lactated Ringer's Injection (B Braun) - Sterility Concern (2025)

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

Class IIModerate

FDAAug 4, 2025Nationwide• B BRAUN MEDICAL INC

RECOMBINATE Antihemophilic Factor (Cardinal Health) – Temperature Deviation (2025)

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

Class IIModerate

FDAJul 30, 2025Nationwide• Cardinal Health Inc.

Sodium Bicarbonate Injection (Exela Pharma) – Arsenic Impurities (2025)

Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.

Class IIModerate

FDAJul 30, 2025Nationwide• Exela Pharma Sciences LLC

Xolair Omalizumab Injection (Cardinal Health) – Temperature Deviation (2025)

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

Class IIModerate

FDAJul 30, 2025Nationwide• Cardinal Health Inc.

Xolair Injection (Cardinal Health) - Temperature Exposure (2025)

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

Class IIModerate

FDAJul 30, 2025Nationwide• Cardinal Health Inc.

Sucralfate Tablets (Amerisource) – Quality Monitoring Failure (2025)

CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

Class IIModerate

FDAJul 29, 2025Nationwide• Amerisource Health Services LLC

Levoxyl Levothyroxine (Pfizer) – Subpotent Drug (2025)

Subpotent drug

Class IIModerate

FDAJul 29, 2025Nationwide• Pfizer

Anabolic Research WINN-50 (Dynamic Sports) – sub-potent supplement (2025)

Dietary supplement involved degradation of an ingredient. Product is sub-potent for Vitamin B12 not meeting label claims.

FDAJul 28, 2025Nationwide• Dynamic Sports Nutrition

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

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

Class IIModerate

FDAJul 25, 2025AZ, IN, NJ• Breckenridge Pharmaceutical, Inc.

Doxepin Hydrochloride Capsules (Alembic) – Nitrosamine Impurity (2025)

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

Class IIModerate

FDAJul 25, 2025Nationwide• Alembic Pharmaceuticals Limited

Wheat Hamburger Buns (Bonami Baking) – Undeclared Allergens (2025)

Undeclared Milk

Undeclared milk and/or eggs from sub-ingredients and/or Contains statement.

Class IIModerate

FDAJul 24, 2025CA• The Bonami Baking Company, Inc.

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