Recalls / Class II
Class IID-0015-2015
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.
- Brand name
- Topiramate
- Generic name
- Topiramate
- Active ingredient
- Topiramate
- Route
- Oral
- NDCs
- 68382-138, 68382-139, 68382-140, 68382-141
- FDA application
- ANDA078235
- Affected lot / code info
- Lot #: MN9828, Expiry: Oct 2015.
Why it was recalled
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
Recalling firm
- Firm
- Zydus Pharmaceuticals USA Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 14,568 Bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2014-09-15
- FDA classified
- 2014-10-10
- Posted by FDA
- 2014-10-22
- Terminated
- 2017-09-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0015-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.