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

FDA recall notice · announced November 1, 2017 · Wockhardt

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot # DR10635, EXP 05/2019; DR10636, EXP 05/2019.
Quantity: 5050 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0051-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.