Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0015-2015·Announced 2014-10-22

Zydus Recalls Topiramate 200 mg Tablets Due to Foreign Tablet Presence

Zydus Pharmaceuticals is recalling Topiramate 200 mg tablets because 100 mg tablets were found mixed in the bottles.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The presence of a different strength of the same medication is a labeling/packaging error that could lead to incorrect dosing, but it is not a Class I hazard involving serious injury or death.

Plain-English summary

Zydus Pharmaceuticals USA Inc. is recalling Topiramate 200 mg tablets, 60 tablet bottles, due to the presence of foreign tablets. The recall involves 14,568 bottles of the medication, which is a prescription-only drug manufactured by Cadila Healthcare Ltd. in Ahmedabad, India, and distributed by Zydus Pharmaceuticals USA Inc. in Pennington, NJ.

The reason for the recall is the presence of topiramate 100 mg tablets comingled with the 200 mg tablets. This means that some bottles may contain a mix of the two different strengths of the medication. The affected product is identified by Lot # MN9828 and has an expiration date of October 2015.

The recall is distributed nationwide in the U.S. Consumers who have this medication should check their bottles for the specific lot number and expiration date. If the product matches the recalled lot, they should stop using it and contact their healthcare provider or pharmacist for instructions on how to return the product or obtain a replacement.

The recalled product

Product: TOPIRAMATE (TOPIRAMATE)
Brand: TOPIRAMATE
Manufacturer: Zydus Pharmaceuticals USA Inc
Category: Drug — Prescription Medication
Hazard: foreign-object
mis-labeling
Affected units: 14,568

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot #: MN9828
Expiry: Oct 2015.

UPCs (4)

0368382140142
0368382141149
0368382139146
0368382138149

Distribution

Distributed nationwide across the United States.

Same brand · TOPIRAMATE

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