Drug product
Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.
D-0912-2018
Product summary
- Event
- Event 80356
- Status
- Terminated
- Classification
- Class III
- Quantity
- 31,710 tablets
- Official record key
drug-enforcement:D-0912-2018
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Batch# DR10445 (Exp: 4/19); Batch# DR10637 (Exp: 5/19); Batch# DR10646 (Exp: 5/19); Batch# DR10647 (Exp: 5/19); Batch# DR10725 (Exp: 7/19); Batch# DR10755 (Exp: 7/19); Batch# DR10811 (Exp: 9/19); Batch# DS10040 (Exp: 12/19); Batch# DS10041 (Exp: 12/19); Batch# DS10024 (Exp: 12/19); and Batch# DS10048 (Exp: 12/19).
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications