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Showing 721–740 of 806 results

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

Presence of foreign substance: Presence of Benzene.

Class IIModerate

FDAMar 5, 2025Nationwide• Strides 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.

Unisom SleepMelts (Chattem) – Nitrosamine Impurity (2025)

CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.

Class IIModerate

FDAMar 4, 2025Nationwide• Chattem Inc

Carvedilol Tablets 6.25mg (Glenmark) – Nitrosamine Risk (2025)

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Class IIModerate

FDAFeb 28, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 25mg (Glenmark) – Nitrosamine Risk (2025)

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Class IIModerate

FDAFeb 28, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 12.5mg (Glenmark) – Nitrosamine Risk (2025)

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Class IIModerate

FDAFeb 28, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Domna's Baklava Tray (Optima Foods) – undeclared milk (2025)

Undeclared Milk

Contains undeclared milk

Class IIModerate

FDAFeb 28, 2025NY• Optima Foods, Inc.

Duloxetine Capsules 30mg (Breckenridge) – Nitrosamine Impurity (2025)

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

Class IIModerate

FDAFeb 28, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Carvedilol Tablets 3.125mg (Glenmark) – Nitrosamine Risk (2025)

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Class IIModerate

FDAFeb 28, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Duloxetine Capsules 20mg (Breckenridge) – Nitrosamine Impurity (2025)

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

Class IIModerate

FDAFeb 28, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Walgreens Acne Control Cleanser (Sigan) – Benzene Contamination (2025)

Chemical Contamination: Presence of benzene

Class IIModerate

FDAFeb 28, 2025Nationwide• Sigan Industries Group Inc.

Duloxetine Capsules 60mg (Breckenridge) – Nitrosamine Impurity (2025)

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

Class IIModerate

FDAFeb 28, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Neupogen 300mcg (Amgen) – Stability Expiration Issue (2025)

Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.

Class IIModerate

FDAFeb 27, 2025Nationwide• Amgen, Inc.

Neupogen 480mcg (Amgen) – Stability Expiration Issue (2025)

Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.

Class IIModerate

FDAFeb 27, 2025Nationwide• Amgen, Inc.

Metformin Extended-Release 500mg (A-S Medication) – Foreign Tablets (2025)

Presence of Foreign Tablets/Capsules.

Class IIModerate

FDAFeb 25, 2025Nationwide• A-S Medication Solutions LLC

Prasugrel Tablets 5mg (Mylan) – Dissolution Failure (2025)

Failed Dissolution Specifications - low dissolution results

Class IIModerate

FDAFeb 25, 2025Nationwide• MYLAN PHARMACEUTICALS INC

Zapzyt Acne Treatment Gel (Denison) – Benzene Contamination (2025)

Chemical Contamination: Presence of benzene.

Class IIModerate

FDAFeb 24, 2025Nationwide• Denison Pharmaceuticals, LLC

Cinnabon Cinnamon Roll Coffee Creamer (Danone Wave) – spoilage risk (2025)

The firm received complaints of spoilage and illness with the use of the products.

Class IIModerate

FDAFeb 21, 2025AL, AR, CO +28 more• DANONE WAVE

Hazelnut Coffee Creamer (Danone Wave) – spoilage risk (2025)

The firm received complaints of spoilage and illness with the use of the products.

Class IIModerate

FDAFeb 21, 2025AL, AR, CO +28 more• DANONE WAVE

Dried Longan Pulp (Growland) – Elevated Sulfite Levels (2025)

Elevated levels of Sulfites in Dried Longan Pulp

Class IIModerate

FDAFeb 18, 2025AZ, CA, FL +5 more• Growland Inc

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