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Recall Observatory FDA recall evidence

Drug product

NIACIN TR, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904062960.

D-1023-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
100 Capsules
Official record key
drug-enforcement:D-1023-2014

Official wording

Reason: Labeling: Label Mixup: NIACIN TR, Capsule, 250 mg may have potentially been mislabeled as the following drug: METHYLERGONOVINE MALEATE, Tablet, 0.2 mg, NDC 43386014028, Pedigree: W003477, EXP: 6/20/2014.

Code information: NIACIN TR, Capsule, 250 mg has the following codes: Pedigree: W003478, EXP: 6/20/2014.

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