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Recall Observatory FDA recall evidence

Drug product

RASAGILINE MESYLATE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68546014256

D-732-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
30 Tablets
Official record key
drug-enforcement:D-732-2014

Official wording

Reason: Labeling:Label Mixup; RASAGILINE MESYLATE, Tablet, 0.5 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W002690, EXP: 6/5/2014.

Code information: RASAGILINE MESYLATE, Tablet, 0.5 mg has the following code Pedigree: W002929, EXP: 6/10/2014.

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