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Recall Observatory FDA recall evidence

Drug product

QUINAPRIL HCL Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762502001

D-650-2014

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-650-2014

Official wording

Reason: Labeling:Label Mixup; QUINAPRIL HCL Tablet, 10 mg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 80 mg, NDC 23155011401, Pedigree: AD42566_4, EXP: 5/14/2014.

Code information: QUINAPRIL HCL, Tablet, 10 mg has the following code Pedigree: AD42611_4, EXP: 5/14/2014.

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