FDAClass IIOctober 22, 2014

TOPIRAMATE Tablets 200 mg recall

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.

Why was TOPIRAMATE Tablets 200 mg recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: MN9828, Expiry: Oct 2015.

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.
Recalling firm
Zydus Pharmaceuticals USA Inc
Quantity
14,568 Bottles
Distribution
U.S. Nationwide
Recall date
October 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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