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Recall Observatory FDA recall evidence

Drug product

CHOLECALCIFEROL, Tablet, 1000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904582460

D-486-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
2,399 Tablets
Official record key
drug-enforcement:D-486-2014

Official wording

Reason: Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 1000 units may be potentially mislabeled as ASPIRIN, Chew Tablet, 81 mg, NDC 00536329736, Pedigree: W003459, EXP: 6/20/2014; MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 37205018581, Pedigree: AD32328_8, EXP: 5/9/2014; CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W002715, EXP: 6/5/2014; GLYCOPYRROLATE, Tablet, 2 mg, NDC 49884006601

Code information: CHOLECALCIFEROL, Tablet, 1000 units has the following codes Pedigree: W003464, EXP: 6/20/2014; Pedigree: AD33897_37, EXP: 5/9/2014; Pedigree: W002779, EXP: 6/6/2014; Pedigree: W003626, EXP: 6/25/2014; Pedigree: W003827, EXP: 6/27/2014; Pedigree: AD33897_34, EXP: 5/9/2014.

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