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Recall Observatory FDA recall evidence

Drug product

BISACODYL EC, Tablet, 5 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904792760

D-493-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
100 Tablets
Official record key
drug-enforcement:D-493-2014

Official wording

Reason: Labeling: Label Mixup; BISACODYL EC, Tablet, 5 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: AD37056_13, EXP: 5/10/2014.

Code information: BISACODYL EC, Tablet, 5 mg has the following code Pedigree: AD34931_1, 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