FDAClass IIJanuary 22, 2014

RILUZOLE Tablet recall: Labeling Error

RILUZOLE Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64980019106

Why was RILUZOLE Tablet recalled?

Labeling: Label Mixup; RILUZOLE Tablet, 50 mg may be potentially mislabeled as traZODone HCl, Tablet, 150 mg, NDC 50111044101, Pedigree: W003245, EXP: 6/17/2014.

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?

RILUZOLE Tablet, 50 mg has the following code Pedigree: W003255, EXP: 6/17/2014.

Product
RILUZOLE Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64980019106
Recalling firm
Aidapak Services, LLC
Quantity
240 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)
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