FDA DrugClass IINotable

FDA Recall: Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharm

Date: 2026-04-08
Brand: Appco Pharma LLC
Category: Drug
FDA Class: Class II

Description

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

Hazard

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

Remedy

28,157 bottles- 100's count

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