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Recall Observatory FDA recall evidence

Drug product

RIBAVIRIN, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68382026007

D-727-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
168 Capsules
Official record key
drug-enforcement:D-727-2014

Official wording

Reason: Labeling:Label Mixup; RIBAVIRIN, Capsule, 200 mg may be potentially mislabeled as MODAFINIL, Tablet, 50 mg (1/2 of 100 MG Tablet), NDC 55253080130, Pedigree: AD21787_4, EXP: 5/1/2014; DESIPRAMINE HCL, Tablet, 50 mg, NDC 45963034302, Pedigree: AD30140_7, EXP: 5/7/2014.

Code information: RIBAVIRIN, Capsule, 200 mg has the following codes Pedigree: AD21790_37, EXP: 4/30/2014; Pedigree: AD30140_13, EXP: 4/30/2014.

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