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Showing 481–500 of 14362 results

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

Cross Contamination

FDAMar 4, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Tolterodine Tartrate (Major Pharmaceuticals) – Dissolution Failure (2025)

Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.

FDAMar 4, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

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

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.

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

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.

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

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 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 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

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

Livalo 4mg (Kowa) – Foreign Tablets (2025)

Presence of foreign tablets/capsules

FDAFeb 24, 2025OH, PA, TX• Kowa Pharmaceuticals America

Vitality Enhancement (One Source) – Undeclared Ingredients (2025)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.

FDAFeb 20, 2025Nationwide• One Source Nutrition, Inc,

Phenylephrine Sodium Chloride (Central Admixture) – Particulate Matter (2025)

Presence of Particulate Matter

FDAFeb 20, 2025Nationwide• Central Admixture Pharmacy Services, Inc.

Vitamin D Supplement (Safecor Health) – Leakage Risk (2025)

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Class IIModerate

FDAFeb 17, 2025Nationwide• Safecor Health, LLC

Ferrous Sulfate Syringe (Safecor Health) – Leakage Risk (2025)

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Class IIModerate

FDAFeb 17, 2025Nationwide• Safecor Health, LLC

Lorazepam Oral Syringe (Safecor Health) – Leakage Risk (2025)

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Class IIModerate

FDAFeb 17, 2025Nationwide• Safecor Health, LLC

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