Status
Terminated
Drug Enforcement D-331-2013
Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.
Classification
Class III
Report Date
May 22, 2013
Termination Date
October 9, 2014
Product Information
- Product description
- 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
- Product quantity
- 9624 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Glenmark Generics Inc., USA
- Address
-
750 Corporate Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-331-2013
- Event ID
- 64995
- Recall initiation date
- April 5, 2013
- Center classification date
- May 16, 2013
- Code info
- Lot# 02123782, Exp 11/14
- More code info
- —