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Showing 1681–1700 of 3363 results

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Deferoxamine Mesylate Injection (Pfizer) – Impurity Concerns (2017)

CGMP Deviations: Firm failed to control impurity for color change at the API stage.

Class IIILow

FDAJul 12, 2017Nationwide• Pfizer Inc.

Halyard Oral Care Kit (Akorn) – chlorhexidine crystallization (2017)

Crystallization with subpotent out of specification assay results for chlorhexidine.

Class IIILow

FDAJul 12, 2017Nationwide• Akorn Inc

Halyard Oral Care Kit (Akorn) – chlorhexidine crystallization (2017)

Crystallization with subpotent out of specification assay results for chlorhexidine.

Class IIILow

FDAJul 12, 2017Nationwide• Akorn Inc

Pravastatin Sodium Tablets (Dr. Reddy's) – Impurity Specification Failure (2017)

Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.

Class IIILow

FDAJul 11, 2017Nationwide• Dr. Reddy's Laboratories, Inc.

Argatroban Injection (Hospira) – Impurity Specification Failure (2017)

Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point

Class IIILow

FDAJul 6, 2017Nationwide• Hospira Inc., A Pfizer Company

Buprenorphine Naloxone Tablets (Teva) – Impurity Concerns (2017)

Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.

Class IIILow

FDAJun 29, 2017Nationwide• Teva Pharmaceuticals USA

Buprenorphine Naloxone Tablets (Teva) – Impurity Concerns (2017)

Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.

Class IIILow

FDAJun 29, 2017Nationwide• Teva Pharmaceuticals USA

C-Therapy Night Cream (Valeant) – Incomplete Packaging (2017)

Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being recalled due to incomplete packaging/labeling. The bottle is missing the product insert and outer carton which contain the complete instruction for use and safety information.

Class IIILow

FDAJun 28, 2017Nationwide• Valeant Pharmaceuticals North America LLC