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Showing 1101–1120 of 2326 results

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Clorazepate Tablets (Aurobindo) – Tablet Discoloration (2024)

Discoloration: Dotted and yellow spots on tablets

Class IIModerate

FDAApr 24, 2024Nationwide• Aurobindo Pharma USA Inc.

Clorazepate Tablets (Aurobindo) – Tablet Discoloration (2024)

Discoloration: Dotted and yellow spots on tablets

Class IIModerate

FDAApr 24, 2024Nationwide• Aurobindo Pharma USA Inc.

Ful-Glo (Nomax) – Impurity Specification Failure (2024)

Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.

Class IIModerate

FDAApr 19, 2024Nationwide• Nomax Inc

Ful-Glo (Nomax) – Impurity Specification Failure (2024)

Class IIModerate

FDAApr 19, 2024Nationwide• Nomax Inc

GloStrips (Nomax) – Impurity Specification Failure (2024)

Class IIModerate

FDAApr 19, 2024Nationwide• Nomax Inc

GloStrips (Nomax) – Impurity Specification Failure (2024)

Class IIModerate

FDAApr 19, 2024Nationwide• Nomax Inc

Amphotericin B Liposome (Sun Pharmaceutical) – Assay Issue (2024)

Out of specification for assay

Class IIModerate

FDAApr 19, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Mocha Hazelnut Wafer (Sacramento Cookie) – Undeclared Milk (2024)

Undeclared Allergen

Undeclared allergen (milk)

Class IIModerate

FDAApr 17, 2024AL, AK, AZ +12 more• Sacramento Cookie Factory

Aloe Gator (ARG Laboratories) – Active Ingredient Issue (2024)

Out of Specification for active ingredient

Class IIModerate

FDAApr 17, 2024Nationwide• ARG Laboratories, Inc.

Golden Tiger Pain Cream (ARG Laboratories) – Active Ingredient Violation (2024)

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

Class IIModerate

FDAApr 17, 2024Nationwide• ARG Laboratories, Inc.

Pain Wizard (ARG Laboratories) – Active Ingredient Violation (2024)

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

Class IIModerate

FDAApr 17, 2024Nationwide• ARG Laboratories, Inc.

Golden Tiger Pain Cream (ARG Laboratories) – Active Ingredient Violation (2024)

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

Class IIModerate

FDAApr 17, 2024Nationwide• ARG Laboratories, Inc.

Bull Frog Sunscreen (ARG Laboratories) – Active Ingredient Issue (2024)

Out of Specification for active ingredient

Class IIModerate

FDAApr 17, 2024Nationwide• ARG Laboratories, Inc.

Golden Tiger Pain Cream (ARG Laboratories) – Active Ingredient Violation (2024)

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

Class IIModerate

FDAApr 17, 2024Nationwide• ARG Laboratories, Inc.

Diltiazem Hydrochloride (Glenmark) – Dissolution Failure (2024)

Failed Dissolution Specifications

Class IIModerate

FDAApr 17, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Pain Wizard (ARG Laboratories) – Active Ingredient Violation (2024)

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

Class IIModerate

FDAApr 17, 2024Nationwide• ARG Laboratories, Inc.

Golden Tiger Pain Cream (ARG Laboratories) – Active Ingredient Violation (2024)

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

Class IIModerate

FDAApr 17, 2024Nationwide• ARG Laboratories, Inc.

Aloe Gator Sunscreen (ARG Laboratories) – Ingredient Specification (2024)

Out of Specification for active ingredient

Class IIModerate

FDAApr 17, 2024Nationwide• ARG Laboratories, Inc.

Pain Wizard (ARG Laboratories) – Active Ingredient Violation (2024)

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

Class IIModerate

FDAApr 17, 2024Nationwide• ARG Laboratories, Inc.

Pain Wizard (ARG Laboratories) – Active Ingredient Violation (2024)

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

Class IIModerate

FDAApr 17, 2024Nationwide• ARG Laboratories, Inc.

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