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Recall Observatory FDA recall evidence

Drug product

TACROLIMUS Capsule, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50742020801

D-597-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
100 Capsules
Official record key
drug-enforcement:D-597-2014

Official wording

Reason: Labeling: Label Mixup; TACROLIMUS, Capsule, 1 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 125 mcg, NDC 00074706890, Pedigree: AD70633_4, EXP: 5/23/2014.

Code information: TACROLIMUS, Capsule, 1 mg has the following code Pedigree: AD60590_1, EXP: 5/29/2014.

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