FDAClass IIJanuary 22, 2014

sulfaSALAzine recall: Labeling Error

sulfaSALAzine, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762500001

Why was sulfaSALAzine recalled?

Labeling:Label Mixup; sulfaSALAzine Tablet, 500 mg may be potentially mislabeled as HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD46265_7, EXP: 5/15/2014.

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?

sulfaSALAzine, Tablet, 500 mg has the following code Pedigree: AD46265_13, EXP: 5/15/2014.

Product
sulfaSALAzine, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762500001
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)
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