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Recall Observatory FDA recall evidence

Drug product

SELEGILINE HCL, Capsule, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 67253070006

D-720-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
60 Capsules
Official record key
drug-enforcement:D-720-2014

Official wording

Reason: Labeling:Label Mixup; SELEGILINE HCL, Capsule, 5 mg may be potentially mislabeled as ITRACONAZOLE, Capsule, 100 mg, NDC 10147170003, Pedigree: AD54549_10, EXP: 5/20/2014.

Code information: SELEGILINE HCL, Capsule, 5 mg has the following code Pedigree: AD54549_19, EXP: 5/20/2014.

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