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Recall Observatory FDA recall evidence

Drug product

quiNIDine SULFATE, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591543801.

D-975-2014

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-975-2014

Official wording

Reason: Labeling: Label Mixup:quiNIDine SULFATE, Tablet, 200 mg may have potentially been mislabeled as the following drug: QUINAPRIL, Tablet, 40 mg, NDC 31722027090, Pedigree: AD52778_76, EXP: 5/21/2014.

Code information: quiNIDine SULFATE, Tablet, 200 mg has the following codes: Pedigree: AD52778_79, 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