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Recall Observatory FDA recall evidence

Drug product

CINACALCET HCL Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55513007330

D-624-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
600 Tablets
Official record key
drug-enforcement:D-624-2014

Official wording

Reason: Labeling:Label Mixup; CINACALCET HCL, Tablet, 30 mg may be potentially mislabeled as ACETAMINOPHEN, Chew Tablet, 80 mg, NDC 00536323307, Pedigree: W003113, EXP: 6/13/2014; FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron), NDC 00904759160, Pedigree: AD54553_1, EXP: 5/20/2014; OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, NDC 00173078302, Pedigree: AD32757_40, EXP: 5/14/2014; COLCHICINE,

Code information: CINACALCET HCL, Tablet, 30 mg has the following codes Pedigree: W003168, EXP: 6/13/2014; Pedigree: AD54516_4, EXP: 5/20/2014; Pedigree: AD32757_50, EXP: 5/14/2014; Pedigree: W003615, EXP: 6/25/2014; Pedigree: AD52778_82, EXP: 5/21/2014; Pedigree: AD73597_13, EXP: 5/31/2014; Pedigree: W003481, EXP: 6/20/2014; Pedigree: W003492, EXP: 6/20/2014.

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