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FDAFDA · Food and drugs·Recall number D-768-2014

ATOMOXETINE HCL, Capsule, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002325030.

Published January 29, 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: ATOMOXETINE HCL, Capsule, 80 mg may be potentially mis-labeled as one of the following drugs: ATOMOXETINE HCL, Capsule, 18 mg, NDC 00002323830, Pedigree: AD30140_16, EXP: 5/7/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, 0 mg, NDC 00904531360, Pedigree: W003706, EXP: 6/25/2014; RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: AD60272_40, EXP: 5/22/2014; PRO

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
ATOMOXETINE HCL, Capsule, 80 mg has the following codes: Pedigree: AD30140_19, EXP: 5/7/2014; Pedigree: W003685, EXP: 6/25/2014; Pedigree: AD60272_49, EXP: 5/22/2014; Pedigree: W003003, EXP: 6/11/2014.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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