Drug product
CINACALCET HCL Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55513007330
D-624-2014
Product summary
- 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
mislabeled