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Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, Rx only, Mfd by: Cadi...

FDA Recall #D-1645-2012 — Class III — July 25, 2012

Recall #D-1645-2012 Date: July 25, 2012 Classification: Class III Status: Terminated

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

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".

Recalling Firm

American Health Packaging — Columbus, OH

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

1,170 cartons

Distribution

Nationwide

Code Information

Lot #: 113032A, 113032B, Exp 04/13

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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