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Recall Observatory FDA recall evidence

Drug product

MYCOPHENOLIC ACID DR, Tablet, 180 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078038566.

D-818-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
120 Tablets
Official record key
drug-enforcement:D-818-2014

Official wording

Reason: Labeling: Label Mixup: MYCOPHENOLIC ACID DR, Tablet, 180 mg may have potentially been mislabeled as the following drug: METHAZOLAMIDE, Tablet, 50 mg, NDC 00781107101, Pedigree: AD37072_11, EXP: 5/13/2014.

Code information: MYCOPHENOLIC ACID DR, Tablet, 180 mg has the following codes: Pedigree: AD37069_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