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Recall Observatory FDA recall evidence

Drug product

PRAMIPEXOLE DI-HCL, Tablet, 1.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462033490

D-731-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
90 Tablets
Official record key
drug-enforcement:D-731-2014

Official wording

Reason: Labeling:Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 1.5 mg may be potentially mislabeled as LIOTHYRONINE SODIUM, Tablet, 25 mcg, NDC 42794001902, Pedigree: AD68010_11, EXP: 5/28/2014.

Code information: PRAMIPEXOLE DI-HCL, Tablet, 1.5 mg has the following code Pedigree: AD68010_20, EXP: 5/28/2014.

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