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Recall Observatory FDA recall evidence

Drug product

CYANOCOBALAMIN, Tablet, 500 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536355101.

D-932-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
700 Tablets
Official record key
drug-enforcement:D-932-2014

Official wording

Reason: Labeling: Label Mixup:CYANOCOBALAMIN, Tablet, 500 mcg was mislabled as SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: W002859, EXP: 6/7/2014. and may have potentially been mislabeled as one of the following drugs: VITAMIN B COMPLEX W/C, Tablet, 0, NDC 00536730001, Pedigree: AD52993_7, EXP: 5/20/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: AD30180_22, EXP:

Code information: CYANOCOBALAMIN, Tablet, 500 mcg has the following codes: Pedigree: AD52993_19, EXP: 5/20/2014; Pedigree: AD30180_25, EXP: 5/9/2014; Pedigree: AD37056_10, EXP: 5/10/2014; Pedigree: AD60578_16, EXP: 5/29/2014; Pedigree: W002860, EXP: 6/7/2014.

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