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FDAFDA · Food and drugs·Recall number D-527-2014

LEFLUNOMIDE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155004303

Published January 22, 2014 · Recall initiated: July 2, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Labeling: Label Mixup; LEFLUNOMIDE Tablet, 10 mg may be potentially mislabeled as DOXYCYCLINE HYCLATE, Capsule, 100 mg, NDC 00143314250, Pedigree: W002645, EXP: 6/5/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: W002623, EXP: 6/4/2014.

What to do

Voluntary: Firm initiated · Telephone

Recall details

Manufacturer
Aidapak Services, LLC
Distributor
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Lot
LEFLUNOMIDE Tablet, 10 mg has the following codes Pedigree: W002659, EXP: 6/5/2014; Pedigree: W002658, EXP: 6/4/2014.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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