FDAClass IIJanuary 29, 2014

sulfaSALAzine recall: Labeling Error

sulfaSALAzine, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603580121.

Why was sulfaSALAzine recalled?

Labeling: Label Mixup: sulfaSALAzine, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: FLUCONAZOLE, Tablet, 200 mg, NDC 00172541360, Pedigree: AD65475_16, EXP: 5/28/2014; PHENYTOIN SODIUM ER, Capsule, 30 mg, NDC 00071374066, Pedigree: W003331, EXP: 6/19/2014.

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?

has the following codes: Pedigree: AD65475_19, EXP: 5/28/2014; Pedigree: W003335, EXP: 6/19/2014.

Product
sulfaSALAzine, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603580121.
Recalling firm
Aidapak Services, LLC
Quantity
299 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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