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Recall Observatory FDA recall evidence

Drug product

carBAMazepine ER Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51672412401

D-604-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
200 Tablets
Official record key
drug-enforcement:D-604-2014

Official wording

Reason: Labeling: Label Mixup; carBAMazepine ER Tablet, 200 mg may be potentially mislabeled as ACARBOSE, Tablet, 25 mg, NDC 00054014025, Pedigree: AD60272_1, EXP: 5/22/2014.

Code information: carBAMazepine ER, Tablet, 200 mg has the following code Pedigree: AD60272_7, EXP: 5/22/2014.

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