Drug product
Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.
D-0913-2018
Product summary
- Event
- Event 80356
- Status
- Terminated
- Classification
- Class III
- Quantity
- 17,628 tablets
- Official record key
drug-enforcement:D-0913-2018
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Batch# DR10447 (Exp: 4/19); Batch# DR10996 (Exp: 10/19); Batch# DS10201 (Exp: 2/20); and Batch# DR10319 (Exp: 3/20).
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications