FDA Drug Class III — Least Serious

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;

Hazard

Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.

Products

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, 2
Brand
Wockhardt Usa Inc.
UPC
Lot # DR10635, EXP 05/2019; DR10636, EXP 05/2019.

Units Affected

5050 bottles