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Recall Observatory FDA recall evidence

Drug product

PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 51991056601

D-606-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
1,399 Tablets
Official record key
drug-enforcement:D-606-2014

Official wording

Reason: Labeling: Label Mixup; PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet may be potentially mislabeled as COLCHICINE, Tablet, 0.6 mg, NDC 64764011907, Pedigree: AD65457_1, EXP: 5/23/2014; GALANTAMINE HBr ER, Capsule, 8 mg, NDC 10147089103, Pedigree: W003509, EXP: 6/21/2014; BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00781532531, Pedigree: AD32579_7, EXP: 5/9/2014; CINACALCET HCL, Tablet, 30 mg, N

Code information: PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet has the following codes Pedigree: AD62829_18, EXP: 5/24/2014; Pedigree: W003511, EXP: 6/21/2014; Pedigree: AD32579_4, EXP: 5/9/2014; Pedigree: AD73597_16, EXP: 5/31/2014; Pedigree: W003086, EXP: 6/12/2014; Pedigree: W003034, EXP: 6/12/2014.

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