Drug Enforcement D-600-2014

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

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
clomiPRAMINE HCl Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51672401205
Product quantity
450 Capsules
Reason for recall
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
Recall initiation reason
—
Initial firm notification
Telephone
Distribution pattern
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Location & Firm

Recalling firm
Aidapak Services, LLC
Address
14301 Se 1st St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-600-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
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.
More code info
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