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U.S. Department of Health and Human Services

Enforcement Report - Week of October 22, 2014

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Product Detail

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.
Recall Number D-0015-2015
Classification Class II
Code Info Lot #: MN9828, Expiry: Oct 2015.
Product Distributed Qty 14,568 Bottles
Reason For Recall Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.

Event Detail

Event Id 69387
Product Type Drugs
Status Ongoing
Recalling Firm Zydus Pharmaceuticals USA Inc
City Pennington
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-09-15
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern U.S. Nationwide
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