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Sulfamethoxazole Trimethoprim Tablets (Northwind Pharmaceuticals) - Foreign Substance (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

FDAAug 20, 2025Nationwide• Northwind Pharmaceuticals LLC

Carvedilol Tablets (Harvard Drug Group) - Impurity Concern (2025)

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Class IIModerate

FDA

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Sulfamethoxazole Trimethoprim Tablets (Northwind Pharmaceuticals) - Foreign Substance (2025)

Carvedilol Tablets (Harvard Drug Group) - Impurity Concern (2025)

Dextroamphetamine Tablets (Lannett Company) - Foreign Tablet (2025)

Chlorpromazine Hydrochloride 50mg (Amneal Pharmaceuticals) - Foreign Substance (2025)

Sodium Chloride Injection (B Braun Medical) - Particulate Matter (2025)

Sulfamethoxazole Trimethoprim (Amneal Pharmaceuticals) - Foreign Substance (2025)

Chlorpromazine Hydrochloride 25mg (Amneal Pharmaceuticals) - Foreign Substance (2025)

Chlorpromazine Hydrochloride 100mg (Amneal Pharmaceuticals) - Foreign Substance (2025)

Chlorpromazine Hydrochloride 200mg (Amneal Pharmaceuticals) - Foreign Substance (2025)

Lactated Ringer's Injection (B Braun Medical) - Particulate Matter (2025)

Ciprofloxacin Dexamethasone Otic Suspension (Sandoz) - Temperature Abuse (2025)

Quesito Colombian Cheese (El Establo) – Listeria risk (2025)

Tavaborole Topical Solution (Viona) - Discoloration (2025)

Graham Cracker Meal (Bakers Authority) – Undeclared allergens (2025)

Lisdexamfetamine Capsules (Lannett) - Label Mix-up (2025)

Duloxetine Capsules (Breckenridge) - CGMP Impurity (2025)

Theophylline Tablets (Glenmark) - Failed Dissolution (2025)

Carvedilol Tablets 3.125mg (Glenmark) - Nitrosamine Impurity (2025)

Carvedilol Tablets 12.5mg (Glenmark) - Nitrosamine Impurity (2025)

Carvedilol Tablets 25mg (Glenmark) - Nitrosamine Impurity (2025)