Drug product
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.
D-0419-2026
Product summary
- Firm
- Appco Pharma LLC
- Event
- Event 98658
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 88,008 bottles- 100's count
- Official record key
drug-enforcement:D-0419-2026
Official wording
Reason: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Code information: Lot:2404160C, Exp.:2026/MAR; 2406253C, Exp.:2026/MAY; 2407311C, Exp.: 2026/JUL; 2407312C, Exp.:2026/JUL; 2408350C, Exp.:2026/JUL; 2505172C, Exp.:2027/MAY; 2506191C, Exp.: 2027/JUN.
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