Drug 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.
D-0420-2026
Product summary
- Firm
- Appco Pharma LLC
- Event
- Event 98658
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 58,896 bottles- 100's count
- Official record key
drug-enforcement:D-0420-2026
Official wording
Reason: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Code information: Lot:2404153UC, Exp.: 2026/MAR; 2404154UC, Exp.:2026/MAR; 2502055UC, Exp.: 2027/JAN; 2505173UC, Exp.: 2027/MAY; 2505175UC, Exp.: 2027/MAY.
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity
-
Manufacturing or process control
cGMP deviation