Recalls / Class II

Class IID-600-2014

Product

clomiPRAMINE HCl Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51672401205

Affected lot / code info

clomiPRAMINE HCl, Capsule, 50 mg has the following codes Pedigree: AD46265_1, EXP: 5/15/2014; Pedigree: W002998, EXP: 6/11/2014; Pedigree: W003675, EXP: 6/25/2014; Pedigree: AD30140_4, EXP: 5/7/2014; Pedigree: AD73525_4, EXP: 5/30/2014.

Why it was recalled

Labeling: Label Mixup; clomiPRAMINE HCl Capsule, 50 mg may be potentially mislabeled as guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: AD46265_25, EXP: 5/15/2014; CHLORTHALIDONE, Tablet, 50 mg, NDC 00378021301, Pedigree: W002988, EXP: 6/11/2014; AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W003674, EXP: 6/25/2014; ISOSORBIDE MONONITRATE, Tablet, 10 mg, NDC 6217501060

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

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

Distribution

Quantity

450 Capsules

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-600-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.