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Showing 821–840 of 2326 results

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Clobazam Tablets (Amerisource) – Foreign Tablet Contamination (2024)

Presence of Foreign Tablets/Capsules

Class IIModerate

FDADec 13, 2024Nationwide• Amerisource Health Services LLC

Dabigatran Etexilate 75mg (Ascend) – Impurity Limit Exceeded (2024)

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

Class IIModerate

FDADec 12, 2024Nationwide• Ascend Laboratories, LLC

Dabigatran Etexilate 150mg (Ascend) – Impurity Limit Exceeded (2024)

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

Class IIModerate

FDADec 12, 2024Nationwide• Ascend Laboratories, LLC

Tutti-Frutti (Three Rivers) - Undeclared Coloring (2024)

Undeclared Allergen

Product contains undeclared FD&C Yellow 5 and FD&C Yellow 6.

Class IIModerate

FDADec 12, 2024CT, DE, MD +6 more• Shata Traders Inc.

Chlorpromazine Tablets 25mg (Glenmark) – Impurity Limit Exceeded (2024)

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

Class IIModerate

FDADec 11, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Chlorpromazine Tablets 10mg (Glenmark) – Impurity Limit Exceeded (2024)

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

Class IIModerate

FDADec 11, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Dapsone Gel 7.5% (VIONA) – Crystallization Issue (2024)

Crystallization

Class IIModerate

FDADec 10, 2024Nationwide• VIONA PHARMACEUTICALS INC

Dapsone Gel 7.5% (Viona) – Crystallization (2024)

Crystallization

Class IIModerate

FDADec 10, 2024Nationwide• VIONA PHARMACEUTICALS INC

MadeGood Chocolate Chip Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

Chocolate Chip Granola Mini Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

Strawberry Granola Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

Mixed Berry Granola Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

Chocolate Banana Granola Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

Made Good Variety Pack (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

Cookies & Creme Granola Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

Chocolate Drizzled Birthday Cake Granola Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

Chocolate Drizzled Cookie Crumble Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

Chocolate Drizzled Vanilla Granola Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

Halloween Chocolate Chip Mini Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

Holiday Sprinkles Granola Mini Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

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