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Recall Observatory FDA recall evidence

Drug product

LOSARTAN POTASSIUM, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093736498.

D-844-2014

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-844-2014

Official wording

Reason: Labeling: Label Mixup: LOSARTAN POTASSIUM, Tablet, 25 mg may have potentially been mislabeled as the following drug: PHYTONADIONE, Tablet, 5 mg, NDC 25010040515, Pedigree: AD46312_22, EXP: 4/30/2014.

Code information: LOSARTAN POTASSIUM, Tablet, 25 mg has the following codes: Pedigree: AD46312_16, EXP: 5/16/2014.

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