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Recall Observatory FDA recall evidence

Drug product

PIOGLITAZONE HCL, Tablet, 15 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093204856.

D-835-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
90 Tablets
Official record key
drug-enforcement:D-835-2014

Official wording

Reason: Labeling: Label Mixup: PIOGLITAZONE HCL, Tablet, 15 mg may have potentially been mislabeled as one of the following drugs: DOXYCYCLINE MONOHYDRATE, Capsule, 100 mg, NDC 49884072703, Pedigree: AD52778_25, EXP: 5/20/2014; LOVASTATIN, Tablet, 20 mg, NDC 00185007201, Pedigree: W003263, EXP: 6/17/2014.

Code information: PIOGLITAZONE HCL, Tablet, 15 mg has the following codes: Pedigree: AD52778_70, EXP: 5/21/2014; Pedigree: W003264, EXP: 6/17/2014.

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