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Recall Observatory FDA recall evidence

Drug product

ETODOLAC Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51672401801

D-601-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
101 Tablets
Official record key
drug-enforcement:D-601-2014

Official wording

Reason: Labeling: Label Mixup; ETODOLAC, Tablet, 400 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, NDC 00032121201, Pedigree: W003731, EXP: 6/26/2014.

Code information: ETODOLAC, Tablet, 400 mg has the following code Pedigree: W003734, EXP: 6/26/2014.

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