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Recall Observatory FDA recall evidence

Drug product

PIMOZIDE Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57844018701

D-633-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
100 Tablets
Official record key
drug-enforcement:D-633-2014

Official wording

Reason: Labeling:Label Mixup; PIMOZIDE Tablet, 2 mg may be potentially mislabeled as DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: AD30140_31, EXP: 5/7/2014.

Code information: PIMOZIDE, Tablet, 2 mg has the following code Pedigree: AD30140_43, EXP: 5/7/2014.

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