FDAClass IIJanuary 22, 2014

Fidaxomicin Tablet recall: Labeling Error

FIDAXOMICIN Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 52015008001

Why was Fidaxomicin Tablet recalled?

Labeling: Label Mixup; FIDAXOMICIN Tablet, 200 mg may be potentially mislabeled as BENAZEPRIL HCL, Tablet, 40 mg, NDC 65162075410, Pedigree: W003918, EXP: 6/28/2014.

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?

FIDAXOMICIN, Tablet, 200 mg has the following code Pedigree: W003920, EXP: 6/28/2014.

Product
FIDAXOMICIN Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 52015008001
Recalling firm
Aidapak Services, LLC
Quantity
120 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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