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Recall Observatory FDA recall evidence

Drug product

BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574010601.

D-953-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
102 Tablets
Official record key
drug-enforcement:D-953-2014

Official wording

Reason: Labeling: Label Mixup: BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg may have potentially been mislabeled as the following drug: CAFFEINE, Tablet, 200 mg, NDC 24385060173, Pedigree: W003725, EXP: 6/26/2014.

Code information: BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg has the following codes: Pedigree: W003754, EXP: 6/26/2014.

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