FDARecalled Apr 8, 2026 · #D-0420-2026
Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11.
Hazard
Class II — temporary health risk
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cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits. Classification: Class II Distribution: U.S.A. Nationwide
Product details
- Product
- Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11.
- Type
- Drugs
- Manufacturer
- Appco Pharma LLC
- Model numbers
- 2404153UC
- UPCs
- —