Recalls / Class III
Class IIID-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
- Brand name
- Topiramate
- Generic name
- Topiramate
- Active ingredient
- Topiramate
- Route
- Oral
- NDCs
- 68462-108, 68462-153, 68462-109, 68462-110
- FDA application
- ANDA077627
- Affected lot / code info
- Lot# 02123782, Exp 11/14
Why it was recalled
Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.
Recalling firm
- Firm
- Glenmark Generics Inc., USA
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 9624 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-04-05
- FDA classified
- 2013-05-16
- Posted by FDA
- 2013-05-22
- Terminated
- 2014-10-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-331-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.