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Showing 301–320 of 29086 results

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Aripiprazole Tablets (Ascend) – Superpotent drug risk (2025)

Superpotent drug

Class IIModerate

FDAAug 28, 2025Nationwide• Ascend Laboratories, LLC

PeriGuard Ointment (DermaRite) – CGMP contamination risk (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

Succinylcholine Chloride Injection (Zydus) – Impurity Specification Failure (2025)

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.

Class IIModerate

FDAAug 27, 2025LA, MS, OH +1 more• Zydus Pharmaceuticals (USA) Inc

4-N-1 Skin Protectant (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

DermaCerin Moisturizing Cream (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

Chlorpromazine Tablets (Amerisource) – Foreign Substance Detected (2025)

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 27, 2025Nationwide• Amerisource Health Services LLC

DermaKleen Antiseptic Soap (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

UltraSure Deodorant (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

PeriGiene Antiseptic (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

Chlorpromazine Tablets (Amerisource) – Foreign Substance Detected (2025)

Class IIModerate

FDAAug 27, 2025Nationwide• Amerisource Health Services LLC

Chlorpromazine Tablets (Amerisource) – Foreign substance packaging (2025)

Class IIModerate

FDAAug 27, 2025Nationwide• Amerisource Health Services LLC

Hand-E-Foam Antiseptic (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

Renew Skin Repair Cream (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

Renew PeriProtect Cream (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

Lantiseptic Skin Protectant (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

Lantiseptic Dry Skin Therapy (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

San-E-Foam Alcohol Sanitizer (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

DermaSarra (DermaRite) – CGMP contamination risk (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

Chlorpromazine Tablets (Amerisource) – Foreign substance packaging (2025)

Class IIModerate

FDAAug 27, 2025Nationwide• Amerisource Health Services LLC

GelRite Hand Sanitizer (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

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