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U.S. Department of Health and Human Services

Enforcement Report - Week of August 22, 2012

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Product Detail

Product Description Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, Rx only, Mfd by: Cadila Healthcare Ltd., Ahmedabad, India; Dist By: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, Pkg by: American Health Packaging, Col. OH 43217, NDC 68084-343-21, blister barcode 6808434311
Recall Number D-1645-2012
Classification Class III
Code Info Lot #: 113032A, 113032B, Exp 04/13
Product Distributed Qty 1,170 cartons
Reason For Recall Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 "Capsules" (3 x 10) rather than "Tablets".

Event Detail

Event Id 62792
Product Type Drugs
Status Ongoing
Recalling Firm American Health Packaging
City Columbus
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-25
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide