FDAClass IIFebruary 18, 2015

Levetiracetam recall: Failed Dissolution

Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389…

Why was Levetiracetam recalled?

Failed Dissolution Specifications: 6 month time point.

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 #: JKN0249A Exp 02/2016

Product
Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389…
Recalling firm
Sun Pharma Global Fze
Quantity
3263 bottles
Distribution
Nationwide.
Recall date
February 18, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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