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Recall Observatory FDA recall evidence

Drug product

ASPIRIN, Tablet, 325 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536330501.

D-928-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
900 Tablets
Official record key
drug-enforcement:D-928-2014

Official wording

Reason: Labeling: Label Mixup: ASPIRIN, Tablet, 325 mg may have potentially been mislabeled as one of the following drugs: PANCRELIPASE DR, Capsule, 0 mg, NDC 42865010302, Pedigree: W003354, EXP: 6/19/2014; acetaZOLAMIDE, Tablet, 250 mg, NDC 51672402301, Pedigree: W003524, EXP: 6/21/2014; METOPROLOL TARTRATE, Tablet, 25 mg, NDC 00378001801, Pedigree: W002535, EXP: 6/3/2014; RIVAROXABAN, Tablet, 20 mg,

Code information: ASPIRIN, Tablet, 325 mg has the following codes: Pedigree: W003355, EXP: 6/19/2014; Pedigree: W003525, EXP: 6/21/2014; Pedigree: W002573, EXP: 6/3/2014; Pedigree: W002624, 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