Drug product
Lisinopril Tablets USP, 20 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 94106 5, NDC 64679-941-06.
D-1347-2015
Product summary
- Event
- Event 71946
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3378 bottles
- Official record key
drug-enforcement:D-1347-2015
Official wording
Reason: CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
Code information: Lot #: DM13219, Exp 10/15; DM13428, Exp 11/15
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations