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Recall Observatory FDA recall evidence

Drug product

ASPIRIN EC, Tablet, 325 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904201360.

D-1025-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
499 Tablets
Official record key
drug-enforcement:D-1025-2014

Official wording

Reason: Labeling: Label Mixup: ASPIRIN EC, Tablet, 325 mg may have potentially been mislabeled as one of the following drugs: MULTIVITAMIN/MULTIMINERAL, CHEW Tablet, 0 mg, NDC 58914001460, Pedigree: AD30180_10, EXP: 5/9/2014; DILTIAZEM HCL ER, Capsule, 240 mg, NDC 49884083109, Pedigree: AD52375_1, EXP: 5/17/2014; ASPIRIN, Tablet, 325 mg, NDC 00536330501, Pedigree: W003355, EXP: 6/19/2014; ASPIRIN, Tab

Code information: ASPIRIN EC, Tablet, 325 mg has the following codes: Pedigree: AD30180_13, EXP: 5/9/2014; Pedigree: AD52378_1, EXP: 5/17/2014; Pedigree: W003356, EXP: 6/19/2014; Pedigree: W003526, EXP: 6/21/2014; Pedigree: AD39588_1, EXP: 5/13/2014.

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