Drug product
Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India, Distributed by: Wockhardt, USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054, USA. NDC: 64679-924-03;
D-0051-2018
Product summary
- Event
- Event 77951
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5050 bottles
- Official record key
drug-enforcement:D-0051-2018
Official wording
Reason: Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Code information: Lot # DR10635, EXP 05/2019; DR10636, EXP 05/2019.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
out of specification