FDAClass IIIMarch 23, 2016

Nabumetone Tablets USP recall: Labeling Error

NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL

Why was Nabumetone Tablets USP recalled?

Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.

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 #: 05N533, Exp 11/16

Product
NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL
Recalling firm
Teva Pharmaceuticals USA
Quantity
576 bottles
Distribution
Nationwide and Puerto Rico.
Recall date
March 23, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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