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Sulfamethoxazole and Trimethoprim (Major) – Foreign substance packaging (2025)

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDASep 2, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Norgestimate and Ethinyl Estradiol (AvKARE) – Content uniformity issue (2025)

Failed Content Uniformity Specifications

Class IIModerate

FDASep 2, 2025Nationwide

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Sulfamethoxazole and Trimethoprim (Major) – Foreign substance packaging (2025)

Norgestimate and Ethinyl Estradiol (AvKARE) – Content uniformity issue (2025)

Dextroamphetamine Saccharate (Granules) – Impurity degradation risk (2025)

Dextroamphetamine Saccharate (Granules) – Impurity degradation risk (2025)

Dextroamphetamine Saccharate (Granules) – Impurity degradation risk (2025)

Dextroamphetamine Saccharate (Granules) – Impurity degradation risk (2025)

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

Dextroamphetamine Saccharate (Granules) – Impurity degradation risk (2025)

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

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

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

DermaMed Skin Ointment (DermaRite) – Manufacturing Contamination (2025)

Cyclobenzaprine Tablets (Unichem) – Labeling Mix-Up (2025)

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

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

DermaSarra (DermaRite) – CGMP contamination risk (2025)

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

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

Sodium Chloride Irrigation (B Braun Medical) - Sterility Concern (2025)

Sterile Water Injection (B Braun Medical) - Sterility Concern (2025)