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Recall Observatory FDA recall evidence

Drug product

NEBIVOLOL HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00456140530.

D-915-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
60 Tablets
Official record key
drug-enforcement:D-915-2014

Official wording

Reason: Labeling: Label Mixup: NEBIVOLOL HCL, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: THYROID, Tablet, 30 mg, NDC 00456045801, Pedigree: AD73611_1, EXP: 5/30/2014; RASAGILINE MESYLATE, Tablet, 0.5 mg, NDC 68546014256, Pedigree: W002929, EXP: 6/10/2014.

Code information: NEBIVOLOL HCL, Tablet, 5 mg has the following codes: Pedigree: AD73611_7, EXP: 5/30/2014; Pedigree: W002930, 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