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Recall Observatory FDA recall evidence

Drug product

PHYTONADIONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 25010040515

D-541-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
500 Tablets
Official record key
drug-enforcement:D-541-2014

Official wording

Reason: Labeling: Label Mixup; PHYTONADIONE Tablet, 5 mg may be potentially mislabeled as medroxyPROGESTERone ACETATE, Tablet, 10 mg, NDC 59762374202, Pedigree: AD46312_19, EXP: 5/16/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W003060, EXP: 6/12/2014; GALANTAMINE HBR ER, Capsule, 24 mg, NDC 47335083783, Pedigree: W003735, EXP: 5/31/2014; TORSEMIDE, Tablet, 10 mg, NDC 31722053001,

Code information: PHYTONADIONE Tablet, 5 mg has the following codes Pedigree: AD46312_22, EXP: 4/30/2014; Pedigree: W003061, EXP: 5/31/2014; Pedigree: W003737, EXP: 5/31/2014; Pedigree: AD25452_1, EXP: 4/30/2014; Pedigree: W003440, EXP: 5/31/2014.

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