Recalls / Class II
Class IID-1346-2015
Product
Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 92806 6, NDC 64679-928-06.
- Affected lot / code info
- Lot #: DM12700, Exp 09/15
Why it was recalled
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
Recalling firm
- Firm
- Wockhardt Usa Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20 Waterview Blvd Ste 3, Parsippany, New Jersey 07054-1271
Distribution
- Quantity
- 1704 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-07-29
- FDA classified
- 2015-08-19
- Posted by FDA
- 2015-08-26
- Terminated
- 2017-04-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1346-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.