PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 22, 2014 Initiated: July 2, 2013 #D-624-2014

Product Description

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

Reason for Recall

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,

Details

Recalling Firm
Aidapak Services, LLC
Units Affected
600 Tablets
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Location
Vancouver, WA

Frequently Asked Questions

What product was recalled?
CINACALCET HCL Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55513007330. Recalled by Aidapak Services, LLC. Units affected: 600 Tablets.
Why was this product recalled?
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,
Which agency issued this recall?
This recall was issued by the FDA Drug on January 22, 2014. Severity: Moderate. Recall number: D-624-2014.