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Recall Observatory FDA recall evidence

Drug product

PIOGLITAZONE, Tablet, 15 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591320530.

D-971-2014

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-971-2014

Official wording

Reason: Labeling: Label Mixup: PIOGLITAZONE, Tablet, 15 mg may have potentially been mislabeled as one of the following drugs: LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: AD21846_31, EXP: 5/1/2014; PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD25452_7, EXP: 5/3/2014; ARIPiprazole, Tablet, 15 mg, NDC 59148000913, Pedigree: AD28322_1, EXP: 5/6/2014.

Code information: PIOGLITAZONE, Tablet, 15 mg has the following codes: Pedigree: AD22845_1, EXP: 4/30/2014; Pedigree: AD25452_10, EXP: 4/30/2014; Pedigree: AD28322_4, EXP: 4/30/2014.

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