FDAClass IIJanuary 22, 2014

METAXALONE Tablet recall: Labeling Error

METAXALONE Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64720032110

Why was METAXALONE Tablet recalled?

Labeling: Label Mixup; METAXALONE Tablet, 800 mg may be potentially mislabeled as ESTERIFIED ESTROGENS, Tablet, 0.625 mg, NDC 61570007301, Pedigree: W003736, EXP: 6/26/2014.

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?

METAXALONE Tablet, 800 mg has the following code Pedigree: W003738, EXP: 6/26/2014.

Product
METAXALONE Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64720032110
Recalling firm
Aidapak Services, LLC
Quantity
100 Tablets
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls