Status
Terminated
Drug Enforcement D-624-2014
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,
Classification
Class II
Report Date
January 22, 2014
Termination Date
February 7, 2014
Product Information
- Product description
- CINACALCET HCL Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55513007330
- Product quantity
- 600 Tablets
- 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,
- 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-624-2014
- Event ID
- 65707
- Recall initiation date
- July 2, 2013
- Center classification date
- January 16, 2014
- Code info
- 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.
- More code info
- —