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Recall Observatory FDA recall evidence

Drug product

OXcarbazepine Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62756018588

D-674-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
100 Tablets
Official record key
drug-enforcement:D-674-2014

Official wording

Reason: Labeling:Label Mixup; OXcarbazepine Tablet, 600 mg may be potentially mislabeled as LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: AD30028_25, EXP: 5/7/2014.

Code information: OXcarbazepine, Tablet, 600 mg has the following code Pedigree: AD30140_46, EXP: 5/7/2014.

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