FDAClass IIJanuary 22, 2014

Fluconazole recall: Labeling Error

FLUCONAZOLE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462010130

Why was Fluconazole recalled?

Labeling:Label Mixup; FLUCONAZOLE, Tablet, 50 mg may be potentially mislabeled as FLUCONAZOLE, Tablet, 200 mg, NDC 00172541360, Pedigree: W003065, EXP: 6/12/2014.

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?

FLUCONAZOLE, Tablet, 50 mg has the following code Pedigree: W003066, EXP: 6/12/2014.

Product
FLUCONAZOLE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462010130
Recalling firm
Aidapak Services, LLC
Quantity
29 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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