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Showing 621–640 of 1639 results

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Timolol Maleate Solution (FDC) – Defective Container (2024)

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

Class IIModerate

FDAOct 29, 2024IN, NJ• FDC Limited

Lanthanum Carbonate Tablets (Cipla) – Broken Tablets (2024)

Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.

Class IIModerate

FDAOct 23, 2024Nationwide• Cipla USA, Inc.

Lanthanum Carbonate Tablets (Cipla) – Broken Tablets (2024)

Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.

Class IIModerate

FDAOct 23, 2024Nationwide• Cipla USA, Inc.

Morphine Sulfate Tablets 30mg (Dr. Reddy's) – Impurity Spec Failure (2024)

Failed Impurities/Degradation Specification

Class IIModerate

FDAOct 22, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Morphine Sulfate Tablets 15mg (Dr. Reddy's) – Impurity Spec Failure (2024)

Failed Impurities/Degradation Specification

Class IIModerate

FDAOct 22, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

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

Labeling: Label Mix-Up

Class IIModerate

FDAOct 18, 2024Nationwide• AvKARE

Sunitinib Capsules 25mg (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 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.

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.

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

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