Drug product
Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90
D-0990-2018
Product summary
- Event
- Event 80397
- Status
- Terminated
- Classification
- Class III
- Quantity
- 11, 90-count bottles
- Official record key
drug-enforcement:D-0990-2018
Official wording
Reason: Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Code information: Lots: 56698-1, EXP 1/31/2019; 56698-2, EXP 4/30/2019
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out-of-specification