Drug recall D-331-2013
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
Reason for recall
Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.
Lots and codes
Lot# 02123782, Exp 11/14
Recall details
- Recalling firm
- Glenmark Generics Inc., USA, Mahwah, NJ
- Quantity
- 9624 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 5, 2013
- Terminated
- October 9, 2014
Related products
- Topiramate – drug information
- NDC 68462-110 Topiramate · Topiramate 200 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-109 Topiramate · Topiramate 100 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-153 Topiramate · Topiramate 50 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-108 Topiramate · Topiramate 25 mg/1 · Glenmark Pharmaceuticals Inc., USA