PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: October 22, 2014 Initiated: September 15, 2014 #D-0015-2015

Product Description

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.

Reason for Recall

Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.

Details

Units Affected
14,568 Bottles
Distribution
U.S. Nationwide
Location
Pennington, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Zydus Pharmaceuticals USA Inc. Units affected: 14,568 Bottles.
Why was this product recalled?
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 22, 2014. Severity: Moderate. Recall number: D-0015-2015.