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Showing 621–640 of 1571 results

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Sunitinib Capsules 12.5mg (AvKARE) – Label Mix-Up (2024)

Labeling: Label Mix-Up

Class IIModerate

FDAOct 18, 2024Nationwide• AvKARE

Perio Maintenance Rinse (Keystone) – Subpotent Drug (2024)

Subpotent Drug

Class IIModerate

FDAOct 17, 2024Nationwide• Keystone Industries

Cinacalcet Tablets 90mg (Accord) – Nitrosamine Impurity (2024)

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Class IIModerate

FDAOct 10, 2024Nationwide• ACCORD HEALTHCARE, INC.

Cinacalcet Tablets 60mg (Accord) – Nitrosamine Impurity (2024)

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Class IIModerate

FDAOct 10, 2024Nationwide• ACCORD HEALTHCARE, INC.

Cinacalcet Tablets 30mg (Accord) – Nitrosamine Impurity (2024)

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Class IIModerate

FDAOct 10, 2024Nationwide• ACCORD HEALTHCARE, INC.

Cinacalcet Tablets 60mg (Dr. Reddy's) – Nitrosamine Impurity (2024)

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

Class IIModerate

FDAOct 9, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Cinacalcet Tablets 30mg (Dr. Reddy's) – Nitrosamine Impurity (2024)

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

Class IIModerate

FDAOct 9, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Cinacalcet Tablets 90mg (Dr. Reddy's) – Nitrosamine Impurity (2024)

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

Class IIModerate

FDAOct 9, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

AK Forte Tablets (C & A) – Undeclared Ingredients (2024)

Undeclared Allergen

Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.

Class IIModerate

FDAOct 8, 2024Nationwide• C & A Naturistics

Cisplatin Injection (Accord Healthcare) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications.

Class IIModerate

FDAOct 1, 2024Nationwide• ACCORD HEALTHCARE, INC.

Ciclopirox Gel (Glenmark) – Broken Tube Seal (2024)

Defective Container: Firm received complaints of broken tube at the seal.

FDASep 30, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Dapsone Gel (Viona) – Crystallization Problem (2024)

Crystallization

Class IIModerate

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

Vail-Bon Jie Yang Wan Capsules (123Herbals) – Undeclared Medications (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.

FDASep 18, 2024Nationwide• 123Herbals

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

Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.

Class IIModerate

FDASep 16, 2024Nationwide• AbbVie Inc.

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

Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.

Class IIModerate

FDASep 16, 2024Nationwide• AbbVie Inc.

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

Undeclared Allergen

Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.

Class IIModerate

FDASep 11, 2024Nationwide• Zhejiang Jingwei Pharmaceutical Co., Ltd.

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

Failed Dissolution Specifications

Class IIModerate

FDASep 3, 2024Nationwide• Ascend Laboratories, LLC

AcetaZOLAMIDE Tablets (Rubicon) – Discoloration (2024)

Discoloration

FDAAug 24, 2024Nationwide• Rubicon Research Private Limited

Semaglutide Multiple Dose Vial (ProRx LLC) – Sterility Concern (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 22, 2024Nationwide• ProRx LLC

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