Recalls / Class III
Class IIID-0051-2018
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;
- Affected lot / code info
- Lot # DR10635, EXP 05/2019; DR10636, EXP 05/2019.
Why it was recalled
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Recalling firm
- Firm
- Wockhardt Usa Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20 Waterview Blvd Ste 3, N/A, Parsippany, New Jersey 07054-1271
Distribution
- Quantity
- 5050 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-08-22
- FDA classified
- 2017-10-26
- Posted by FDA
- 2017-11-01
- Terminated
- 2019-02-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0051-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.