Recalls / Class II

Class IID-713-2014

Product

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

Affected lot / code info

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.

Why it was recalled

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

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

14301 Se 1st St, Vancouver, Washington 98684-3501

Distribution

Quantity

799 Tablets

Distribution pattern

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Timeline

Recall initiated

2013-07-02

FDA classified

2014-01-16

Posted by FDA

2014-01-22

Terminated

2014-02-07

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-713-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.