Recall: D-0015-2015

Class II - Potentially Harmful

Class IIClassification

2014-09-15Initiated

TerminatedStatus

Zydus Pharmaceuticals USA IncFirm

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.

Reason

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

Distribution

U.S. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.