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Fludrocortisone Acetate Tablets (Teva) – Impurity Concerns (2024)

Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.

Class IIModerate

FDAJun 28, 2024Nationwide• Teva Pharmaceuticals USA, Inc

Pravastatin Sodium Tablets (Glenmark) – Dissolution Failure (2024)

Failed Dissolution Specifications: results below specifications

Class IIModerate

FDAJun 28, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

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Fludrocortisone Acetate Tablets (Teva) – Impurity Concerns (2024)

Pravastatin Sodium Tablets (Glenmark) – Dissolution Failure (2024)

Infla-650 Herbal Supplement (Guru) – Undeclared Ingredients (2024)

Bupropion Extended-Release Tablets (Amerisource) – Dissolution Issue (2024)

Dream Cream (Little Moon Essentials) – CGMP Issues (2024)

Aching Head Rub (Little Moon Essentials) – CGMP Issues (2024)

Ass Kisser (Little Moon Essentials) – CGMP Issues (2024)

Vital Vapor Balm (Little Moon Essentials) – CGMP Issues (2024)

Clear Breeze Plus Hand Sanitizer (Little Moon Essentials) – CGMP Issues (2024)

Asana Kisser (Little Moon Essentials) – Manufacturing Deviation (2024)

Magical Muscle Oil (Little Moon Essentials) – CGMP Issues (2024)

Crampy Belly Rub (Little Moon Essentials) – CGMP Issues (2024)

Organic Sunrise Energy Bars (Universal Bakery) – Undeclared gluten (2024)

Organic Aussie Bites (Universal Bakery) – Undeclared gluten (2024)

Delflex Peritoneal Dialysis Solution (Fresenius) – Tube Weld Failure (2024)

Paleo Bars (SureLife Foods) – Undeclared gluten (2024)

Dianeal Low Calcium Dialysis Solution (Baxter) – Sterility Risk (2024)

Zilretta (Pacira) – Dissolution Specifications (2024)

Oatmeal Body Lotion (Brands International) – Mold Contamination (2024)

Amoxicillin Chewable Tablets (Teva) – Subpotent Drug (2024)