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Recall Observatory FDA recall evidence

Drug product

TRIFLUOPERAZINE HCL, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781103001.

D-997-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
100 Tablets
Official record key
drug-enforcement:D-997-2014

Official wording

Reason: Labeling: Label Mixup: TRIFLUOPERAZINE HCL, Tablet, 1 mg may have potentially been mislabeled as the following drug: TERBUTALINE SULFATE, Tablet, 2.5 mg, NDC 00115261101, Pedigree: AD52778_88, EXP: 5/21/2014.

Code information: TRIFLUOPERAZINE HCL, Tablet, 1 mg has the following codes: Pedigree: AD52778_91, EXP: 5/21/2014.

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