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Recall Observatory FDA recall evidence

Drug product

methylPREDNISolone Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59746000103

D-642-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
21 Tablets
Official record key
drug-enforcement:D-642-2014

Official wording

Reason: Labeling:Label Mixup; methylPREDNISolone Tablet, 4 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 137 mcg, NDC 00781519192, Pedigree: AD22616_10, EXP: 5/2/2014.

Code information: methylPREDNISolone, Tablet, 4 mg has the following code Pedigree: AD21811_17, EXP: 5/1/2014.

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