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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 00574010603.

D-954-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
63 Tablets
Official record key
drug-enforcement:D-954-2014

Official wording

Reason: Labeling: Label Mixup: BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg may have potentially been mislabeled as one of the following drugs: BENAZEPRIL HCL, Tablet, 40 mg, NDC 65162075410, Pedigree: AD68010_1, EXP: 5/28/2014; THIORIDAZINE HCL, Tablet, 50 mg, NDC 00378061601, Pedigree: AD73525_28, EXP: 5/30/2014.

Code information: BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg has the following codes: Pedigree: AD68010_4, EXP: 5/28/2014; Pedigree: AD73525_40, EXP: 5/30/2014.

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