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Recall Observatory FDA recall evidence

Drug product

BENAZEPRIL HCL Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162075410

D-713-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
799 Tablets
Official record key
drug-enforcement:D-713-2014

Official wording

Reason: Labeling:Label Mixup; BENAZEPRIL HCL Tablet, 40 mg may be potentially mislabeled as NEFAZODONE HCL, Tablet, 200 mg, NDC 00093102506, Pedigree: AD46414_44, EXP: 5/16/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: W003931, EXP: 6/28/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD42592_1, EXP: 5/14/2014; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/25

Code information: BENAZEPRIL HCL Tablet, 40 mg has the following codes Pedigree: AD49423_1, EXP: 5/16/2014; Pedigree: W003918, EXP: 6/28/2014; Pedigree: AD32757_7, EXP: 5/13/2014; Pedigree: AD68010_1, 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