Drug product
Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0669-01.
D-1268-2015
Product summary
- Event
- Event 71104
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16,276 Bottles
- Official record key
drug-enforcement:D-1268-2015
Official wording
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Code information: Lot #: LN11008, Expiry: 4/30/2015.
Distribution pattern: U.S. Nationwide including Puerto Rico.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations