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Dapsone Gel (Viona) – Crystallization Problem (2024)

Crystallization

FDASep 24, 2024NY• VIONA PHARMACEUTICALS INC

Atorvastatin Tablets (Nivagen) – Foreign Tablet Contamination (2024)

Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.

Class IIModerate

FDASep 24, 2024Nationwide• Nivagen Pharmaceuticals Inc

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Dapsone Gel (Viona) – Crystallization Problem (2024)

Atorvastatin Tablets (Nivagen) – Foreign Tablet Contamination (2024)

Ryaltris Nasal Spray (Glenmark) – Clogged Delivery System (2024)

Pluvicto Injection (Advanced Accelerator) – Manufacturing Deviations (2024)

EnviroClean Hand Sanitizer Gel (EnviroServe) – CGMP Issues (2024)

Refresh P.M. Eye Ointment (AbbVie) – Tube Seal Breach (2024)

Refresh LACRI-LUBE (AbbVie) – Tube Seal Breach (2024)

First Aid Antiseptic Ointment (Zhejiang Jingwei) – Incorrect Ingredients (2024)

Minute Maid Lemonade (Coca-Cola) – Mislabeled Product (2024)

Mycophenolic Acid Tablets (Ascend) – Dissolution Failure (2024)

Vivier Sheer SPF 30 (Vivier) – Microbial Contamination (2024)

Kara Boondhi (Grace Imports) - Undeclared Wheat (2024)

Spicy Murukku Ingredients (Grace Imports) - Undeclared Wheat (2024)

Kerala Mixture (Grace Imports) - Undeclared Wheat (2024)

Barrier Therapy Skin Cream (PreQuel) – Microbial Contamination (2024)

Chocolate Milk (Big Bottom) - Pasteurization Issue (2024)

Chocolate Milk (Big Bottom) - Pasteurization Issue (2024)

Chocolate Milk (Big Bottom) - Pasteurization Issue (2024)

Blueberry Muffin (Posh Bakery) - Undeclared Allergens (2024)

Apple Cinnamon Muffin (Posh Bakery) - Undeclared Allergens (2024)