Product: PRAZOSIN HYDROCHLORIDE Classification: Class II Reason for recall: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits. Product description: Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11. Recalling firm: Appco Pharma LLC Product type: Drugs
FDA MedWatch published a clinical safety alert in Pharmacology on 08 Apr 2026.
The item focuses on PRAZOSIN HYDROCHLORIDE: Class II recall update.
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