FDAClass IIJanuary 22, 2014

Naproxen recall: Labeling Error

NAPROXEN, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 05374601901

Why was Naproxen recalled?

Labeling: Label Mixup; NAPROXEN, Tablet, 500 mg may be potentially mislabeled as THIOTHIXENE, Capsule, 1 mg, NDC 00378100101, Pedigree: AD54549_22, EXP: 5/20/2014; HYDROCHLOROTHIAZIDE, Tablet, 12.5 mg, NDC 00228282011, Pedigree: AD67989_13, EXP: 5/28/2014.

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?

NAPROXEN, Tablet, 500 mg has the following codes Pedigree: AD54516_1, EXP: 5/20/2014; Pedigree: AD68025_8, EXP: 5/28/2014.

Product
NAPROXEN, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 05374601901
Recalling firm
Aidapak Services, LLC
Quantity
200 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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