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Recall Observatory FDA recall evidence

Drug product

CYANOCOBALAMIN, Tablet, 1000 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904421713

D-466-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
1,821 Tablets
Official record key
drug-enforcement:D-466-2014

Official wording

Reason: Labeling: Label Mixup; CYANOCOBALAMIN, Tablet, 1000 mcg may be potentially mislabeled as VITAMIN B COMPLEX W/C, Tablet, NDC 00904026013, Pedigree: AD21846_43, EXP: 5/1/2014; NIACIN TR, Capsule, 500 mg, NDC 00904063160, Pedigree: AD46257_22, EXP: 5/15/2014; chlorproMAZINE HCl, Tablet, 50 mg, NDC 00832030200, Pedigree: AD32973_4, EXP: 5/9/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, NDC

Code information: CYANOCOBALAMIN, Tablet, 1000 mcg has the following codes Pedigree: AD21846_46, EXP: 5/1/2014; Pedigree: AD46257_59, EXP: 5/15/2014; Pedigree: AD32582_3, EXP: 5/9/2014; Pedigree: AD60240_51, EXP: 5/22/2014; Pedigree: W002839, EXP: 6/7/2014; Pedigree: W003026, EXP: 6/12/2014; Pedigree: W003075, EXP: 6/12/2014; Pedigree: W003322, EXP: 6/19/2014.

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