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Recall Observatory FDA recall evidence

Drug product

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

D-600-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
450 Capsules
Official record key
drug-enforcement:D-600-2014

Official wording

Reason: 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

Code information: 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.

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