FDAClass IIJanuary 29, 2014

Nabumetone recall: Labeling Error

NABUMETONE, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00185014501.

Why was Nabumetone recalled?

Labeling: Label Mixup: NABUMETONE, Tablet, 500 mg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: AD46429_1, EXP: 5/15/2014.

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?

NABUMETONE, Tablet, 500 mg has the following codes: Pedigree: AD46426_4, EXP: 5/15/2014.

Product
NABUMETONE, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00185014501.
Recalling firm
Aidapak Services, LLC
Quantity
100 Tablets
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 29, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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