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;
Reason for recall: Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Recall initiated: 20170822
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated