Drug product
Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90
D-0991-2018
Product summary
- Event
- Event 80397
- Status
- Terminated
- Classification
- Class III
- Quantity
- 61, 90-count bottles
- Official record key
drug-enforcement:D-0991-2018
Official wording
Reason: Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Code information: Lots: 51904-1, EXP: 01/31/2018; 51904-4, 52885-1, EXP: 03/31/2018; 52885-3, EXP: 04/30/2018; 52885-4,EXP: 05/28/2018; 53840-2,EXP: 5/28/2018; 53840-3, EXP:6/30/2018; 53840-4, EXP:8/31/2018; 56665-1, EXP: 01/31/2019; 58596-1, EXP: 05/28/2019.
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out-of-specification