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Recall Observatory FDA recall evidence

Drug product

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

D-768-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
120 Capsules
Official record key
drug-enforcement:D-768-2014

Official wording

Reason: 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

Code information: 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.

Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mixup