FDAFDA · Food and drugs·Recall number D-0051-2018
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;
Published November 1, 2017 · Recall initiated: August 22, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Wockhardt Usa Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot # DR10635, EXP 05/2019; DR10636, EXP 05/2019.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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