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Recall Observatory FDA recall evidence

Drug product

CARBIDOPA/LEVODOPA, Tablet, 25 mg/250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093029401.

D-823-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
100 Tablets
Official record key
drug-enforcement:D-823-2014

Official wording

Reason: Labeling: Label Mixup: CARBIDOPA/LEVODOPA, Tablet, 25 mg/250 mg may have potentially been mislabeled as the following drug: DIGOXIN, Tablet, 0.125 mg, NDC 00115981101, Pedigree: AD46426_22, EXP: 5/15/2014.

Code information: CARBIDOPA/LEVODOPA, Tablet, 25 mg/250 mg has the following codes: Pedigree: AD46426_28, EXP: 5/15/2014.

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