Warning
Appco Pharma LLC Recalls Prazosin Hydrochloride Capsules
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0419-2026Drug / Pharmaceutical
Appco Pharma LLC Recalls Prazosin Hydrochloride Capsules
Appco Pharma LLC · Class II — Moderate Risk
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.
Reason for Recall
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
U.S.A. Nationwide
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database