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Recall Observatory FDA recall evidence

Drug product

ARIPiprazole Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59148000613

D-639-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
180 Tablets
Official record key
drug-enforcement:D-639-2014

Official wording

Reason: Labeling:Label Mixup; ARIPiprazole Tablet, 2 mg may be potentially mislabeled as tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: AD21790_40, EXP: 5/1/2014; ATOMOXETINE HCL, Capsule, 80 mg, NDC 00002325030, Pedigree: AD30140_19, EXP: 5/7/2014; OLANZapine, Tablet, 7.5 mg, NDC 55111016530, Pedigree: AD46265_46, EXP: 5/15/2014; REPAGLINIDE, Tablet, 2 mg, NDC 00169008481, Pedigree: AD464

Code information: ARIPiprazole, Tablet, 2 mg has the following codes Pedigree: AD21790_43, EXP: 5/1/2014; Pedigree: AD30140_25, EXP: 5/7/2014; Pedigree: AD46265_19, EXP: 5/15/2014; Pedigree: AD46414_1, EXP: 5/16/2014; Pedigree: W003004, 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

    mislabeled