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Recall Observatory FDA recall evidence

Drug product

CHOLECALCIFEROL, Tablet, 400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904582360

D-485-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
1,199 Tablets
Official record key
drug-enforcement:D-485-2014

Official wording

Reason: Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 400 units may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: AD37056_10, EXP: 5/10/2014; ROSUVASTATIN CALCIUM, Tablet, 5 mg, NDC 00310075590, Pedigree: W002567, EXP: 6/3/2014; PYRIDOXINE HCL, Tablet, 100 mg, NDC 00536440901, Pedigree: AD76686_4, EXP: 5/31/2014; CYANOCOBALAMIN, Tablet, 500 mcg, NDC 0053

Code information: CHOLECALCIFEROL, Tablet, 400 units has the following codes Pedigree: AD37056_13, EXP: 5/10/2014; Pedigree: W002574, EXP: 6/3/2014; Pedigree: AD76686_7, EXP: 5/31/2014; Pedigree: AD60578_27, EXP: 5/29/2014; Pedigree: W003540, EXP: 6/21/2014; Pedigree: AD52993_25, EXP: 5/20/2014; Pedigree: W002715, EXP: 6/5/2014; Pedigree: AD30197_31, EXP: 5/9/2014; Pedigree: AD73592_8, EXP: 5/31/2014; Pedigree: W002642, EXP: 6/4/2014.

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