Class III
Terminated
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;
- Company
- Wockhardt Usa Inc.
- Recall Initiated
- August 22, 2017
- Posted
- November 1, 2017
- Recall Number
- D-0051-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5050 bottles
- Firm Location
- Parsippany, NJ, United States
Reason for Recall
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Distribution
Nationwide in the USA
Lot / Code Info
Lot # DR10635, EXP 05/2019; DR10636, EXP 05/2019.
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