Drug product
Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0374-09.
D-1266-2015
Product summary
- Event
- Event 71104
- Status
- Terminated
- Classification
- Class II
- Quantity
- 539 Drums
- Official record key
drug-enforcement:D-1266-2015
Official wording
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Code information: Lot #: LN11320, Expiry: 7/31/2015; Lot #: LN11341, Expiry: 8/31/2015.
Distribution pattern: U.S. Nationwide including Puerto Rico.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations