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Recall Observatory FDA recall evidence

Drug product

BENAZEPRIL HCL Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162075110

D-712-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
100 Tablets
Official record key
drug-enforcement:D-712-2014

Official wording

Reason: Labeling:Label Mixup; BENAZEPRIL HCL Tablet, 5 mg may be potentially mislabeled as ZINC SULFATE, Capsule, 220 mg, NDC 60258013101, Pedigree: AD52993_34, EXP: 5/20/2014.

Code information: BENAZEPRIL HCL Tablet, 5 mg has the following code Pedigree: AD52778_7, EXP: 5/20/2014.

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