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Recall Observatory FDA recall evidence

Drug product

ATOMOXETINE HCL, Capsule, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002322930.

D-765-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
180 Capsules
Official record key
drug-enforcement:D-765-2014

Official wording

Reason: Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 40 mg may be potentially mis-labeled as OLANZAPINE, Tablet, 7.5 mg, NDC 60505311203, Pedigree: AD21790_76, EXP: 5/1/2014; ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD46265_19, EXP: 5/15/2014; OLANZapine, Tablet, 7.5 mg, NDC 55111016530, Pedigree: AD60272_79, EXP: 5/22/2014; OLANZapine, Tablet, 7.5 mg, NDC 55111016530, Pedigree: AD73

Code information: ATOMOXETINE HCL, Capsule, 40 mg has the following codes: Pedigree: AD21790_82, EXP: 5/1/2014; Pedigree: AD46265_52, EXP: 5/15/2014; Pedigree: AD60272_89, EXP: 5/22/2014; Pedigree: AD73525_67, EXP: 5/30/2014; Pedigree: W003014, 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