Drug recall D-0015-2015

Class II Terminated reported Oct 22, 2014

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 for recall

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

Lots and codes

Lot #: MN9828, Expiry: Oct 2015.

Recall details

Recalling firm
Zydus Pharmaceuticals USA Inc, Pennington, NJ
Quantity
14,568 Bottles
Distribution
U.S. Nationwide
Type
Voluntary: Firm initiated
Recall initiated
September 15, 2014
Terminated
September 20, 2017

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