FDAClass IIJanuary 22, 2014

Lurasidone HCL recall: Labeling Error

LURASIDONE HCL, Tablet, 120 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63402031230

Why was Lurasidone HCL recalled?

Labeling:Label Mixup; LURASIDONE HCl Tablet, 120 mg may be potentially mislabeled as DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003486, EXP: 6/20/2014.

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?

LURASIDONE HCL, Tablet, 120 mg has the following code Pedigree: W003487, EXP: 6/20/2014.

Product
LURASIDONE HCL, Tablet, 120 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63402031230
Recalling firm
Aidapak Services, LLC
Quantity
60 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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