Drug product
TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC 68382-141-14.
D-0015-2015
Product summary
- Event
- Event 69387
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,568 Bottles
- Official record key
drug-enforcement:D-0015-2015
Official wording
Reason: Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
Code information: Lot #: MN9828, Expiry: Oct 2015.
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets