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Recall Observatory FDA recall evidence

Drug product

PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904531360

D-478-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
1,501 Tablets
Official record key
drug-enforcement:D-478-2014

Official wording

Reason: Labeling: Label Mixup; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled as RILUZOLE, Tablet, 50 mg, NDC 00075770060, Pedigree: AD62992_11, EXP: 5/23/2014; ASPIRIN, Chew Tablet, 81 mg, NDC 00536329736, Pedigree: W003093, EXP: 6/13/2014; NIACIN TR, Capsule, 250 mg, NDC 00904062960, Pedigree: W003478, EXP: 6/20/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 009045

Code information: PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet has the following codes Pedigree: AD62986_22, EXP: 5/23/2014; Pedigree: W003098, EXP: 6/13/2014; Pedigree: W003479, EXP: 6/20/2014; Pedigree: W003480, EXP: 6/20/2014; Pedigree: AD52993_13, EXP: 5/20/2014; Pedigree: AD60428_7, EXP: 5/22/2014; Pedigree: AD73652_16, EXP: 5/30/2014; Pedigree: W003706, 6/25/2014.

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