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Recall Observatory FDA recall evidence

Drug product

ASPIRIN Tablet, 325 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49348000123

D-582-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
300 Tablets
Official record key
drug-enforcement:D-582-2014

Official wording

Reason: Labeling: Label Mixup; ASPIRIN Tablet, 325 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W002642, EXP: 6/4/2014.

Code information: ASPIRIN, Tablet, 325 mg has the following code Pedigree: W002640, 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