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Recall Observatory FDA recall evidence

Drug product

CYANOCOBALAMIN, Tablet, 1000 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536355601.

D-933-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
923 Tablets
Official record key
drug-enforcement:D-933-2014

Official wording

Reason: Labeling: Label Mixup: CYANOCOBALAMIN, Tablet, 1000 mcg may have potentially been mislabeled as one of the following drugs: VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50 mg, NDC 40985022251, Pedigree: AD30180_19, EXP: 5/9/2014; COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: AD37056_4, EXP: 5/10/2014. VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 0, NDC 40985022251, Pedigree: AD7362

Code information: CYANOCOBALAMIN, Tablet, 1000 mcg may have potentially been mislabeled as one of the following drugs: VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50 mg, NDC 40985022251, Pedigree: AD30180_19, EXP: 5/9/2014; COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: AD37056_4, EXP: 5/10/2014. VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 0, NDC 40985022251, Pedigree: AD73627_26, EXP: 5/30/2014; PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: W003856, EXP: 6/26/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003052, EXP: 6/12/2014; VENLAFAXINE HCL, Tablet, 50 mg, NDC 23155024801, Pedigree: AD65475_22, EXP: 5/28/2014; CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: AD32757_50, EXP: 5/14/2014.

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