FDAClass IIJanuary 22, 2014

Itraconazole recall: Labeling Error

ITRACONAZOLE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 10147170003

Why was Itraconazole recalled?

Labeling: Label Mixup; ITRACONAZOLE, Capsule, 100 mg may be potentially mislabeled as FAMCICLOVIR, Tablet, 500 mg, NDC 00093811956, Pedigree: AD54549_4, EXP: 5/20/2014.

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?

ITRACONAZOLE, Capsule, 100 mg has the following code Pedigree: AD54549_10, EXP: 5/20/2014.

Product
ITRACONAZOLE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 10147170003
Recalling firm
Aidapak Services, LLC
Quantity
30 Capsules
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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