Drug product
Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30
D-0992-2018
Product summary
- Event
- Event 80397
- Status
- Terminated
- Classification
- Class III
- Quantity
- 25, 30-count bottles
- Official record key
drug-enforcement:D-0992-2018
Official wording
Reason: Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Code information: Lots: 51904-2, EXP: 01/31/2018; 51904-3, EXP: 02/28/2018; 51904-5, EXP: 03/31/2018; 52885-2, EXP: 03/31/2018, 53840-1, EXP: 5/28/2018.
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out-of-specification