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Showing 381–400 of 29086 results

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Carvedilol Tablets 25mg (Glenmark) - Nitrosamine Impurity (2025)

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Class IIModerate

FDAAug 7, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Lemon Pepper Seasoning (QST Ingredients) – Metal fragment risk (2025)

Product may contain small metal fragments due to contaminated onion powder ingredient used in manufacturing.

Class IIModerate

FDAAug 7, 2025CA, IN, OR +1 more• QST Ingredients and Packaging

BBQ Riblet Seasoning (QST Ingredients) – Metal fragment risk (2025)

Product may contain small metal fragments due to contaminated onion powder ingredient used in manufacturing.

Class IIModerate

FDAAug 7, 2025CA, IN, OR +1 more• QST Ingredients and Packaging

Maple Nut Fudge (The Candy Barn) – Undeclared Allergens (2025)

Allergen labeling: specific tree nut (pecan) and egg not listed in 'contains' statement

Class IIModerate

FDAAug 6, 2025IA• The Candy Barn

Carvedilol Tablets 25mg (Glenmark) - Nitrosamine Excess (2025)

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Class IIModerate

FDAAug 6, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 12.5mg (Glenmark) - Nitrosamine Excess (2025)

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Class IIModerate

FDAAug 6, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Metoprolol Tablets 50mg (Westminster) - Nitrosamine Risk (2025)

CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

Class IIModerate

FDAAug 6, 2025Nationwide• Westminster Pharmaceuticals LLC

Metoprolol Tablets 100mg (Westminster) - Nitrosamine Risk (2025)

CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

Class IIModerate

FDAAug 6, 2025Nationwide• Westminster Pharmaceuticals LLC

Pecan Toffee Clusters (The Candy Barn) – Missing Allergen Info (2025)

Allergen labeling: specific tree nut (pecan) not listed in 'contains' statement

Class IIModerate

FDAAug 6, 2025IA• The Candy Barn

Chocolate Pecan Fudge (The Candy Barn) – Missing Allergen Info (2025)

Allergen labeling: specific tree nut (pecan) and egg are not listed in the 'contains' statement

Class IIModerate

FDAAug 6, 2025IA• The Candy Barn

Chocolate Mint Fudge (The Candy Barn) – Missing Allergen Info (2025)

Allergen labeling: egg is not listed in the 'contains' statement

Class IIModerate

FDAAug 6, 2025IA• The Candy Barn

Peanut Butter Fudge (Candy Barn) – Undeclared egg (2025)

Allergen labeling: egg not listed in the 'contains' statement

Class IIModerate

FDAAug 6, 2025IA• The Candy Barn

Chocolate Walnut Fudge (The Candy Barn) – Missing Allergen Info (2025)

Allergen labeling: specific tree nut (walnut) and egg are not listed in the 'contains' statement

Class IIModerate

FDAAug 6, 2025IA• The Candy Barn

Peanut Brittle (The Candy Barn) – Missing Allergen Info (2025)

Allergen labeling: missing allergens (peanuts, milk) in contains statement

Class IIModerate

FDAAug 6, 2025IA• The Candy Barn

Chocolate Fudge (The Candy Barn) – Missing Allergen Info (2025)

Allergen labeling: egg is not listed in the 'contains' statement

Class IIModerate

FDAAug 6, 2025IA• The Candy Barn

English Toffee (The Candy Barn) – Missing Allergen Info (2025)

Allergen labeling: specific tree nut (pecans) not listed in the 'contains' statement

Class IIModerate

FDAAug 6, 2025IA• The Candy Barn

Spironolactone Tablets (Sun Pharma) - Foreign Substance (2025)

Presence of foreign substance: identified as aluminum.

Class IIModerate

FDAAug 5, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Ramen Noodles (Kobayashi) – Undeclared Soy (2025)

Ramen Noodle package label does not declare Soy as the source for lecithin ingredient.

Class IIModerate

FDAAug 5, 2025CA• Kobayashi Noodle U.S.A.

Enoxaparin Sodium Injection (Cardinal Health) - Product Mispack (2025)

Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL

Class IIModerate

FDAAug 5, 2025KS• Cardinal Health Inc.

Frozen Half Shell Oysters (Khee Trading) – Norovirus Risk (2025)

Imported Frozen Oyster potentially contaminated with Norovirus.

Class IIModerate

FDAAug 5, 2025AZ, CA, NV +1 more• Khee Trading, Inc.

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