Reported Nov 1, 2017 · Terminated
Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C.…
Wockhardt USA Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Wockhardt Usa Inc. · 20 Waterview Blvd Ste 3 · Parsippany, NJ · 07054-1271
Is this the product you have?
- Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only
- Manufactured byWockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India
- Distributed byWockhardt, USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054, USA
- NDC64679-924-03
- Lot codes and dates
Lot # DR10635EXP 05/2019DR10636EXP 05/2019
- Amount recalled
- 5050 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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