Drug product
Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for : Glenmark Generics USA Mahwah, NJ 07430
D-331-2013
Product summary
- Event
- Event 64995
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9624 bottles
- Official record key
drug-enforcement:D-331-2013
Official wording
Reason: Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.
Code information: Lot# 02123782, Exp 11/14
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination