D-667-2014 Class II Terminated

Recalled by Aidapak Services, LLC — Vancouver, WA

Recall Details

Product Type
Drugs
Report Date
January 22, 2014
Initiation Date
July 2, 2013
Termination Date
February 7, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
840 Tablets

Product Description

RANOLAZINE ER Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 61958100301

Reason for Recall

Labeling:Label Mixup; RANOLAZINE ER Tablet, 500 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD25452_16, EXP: 5/3/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: AD70585_16, EXP: 5/29/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W002852, EXP: 6/7/2014; VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree:

Distribution Pattern

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Code Information

RANOLAZINE ER, Tablet, 500 mg has the following codes Pedigree: AD23087_1, EXP: 5/2/2014; Pedigree: AD62995_7, EXP: 5/29/2014; Pedigree: W002857, EXP: 6/7/2014; Pedigree: W003538, EXP: 6/21/2014; Pedigree: W003741, EXP: 6/26/2014; Pedigree: AD32757_47, EXP: 5/13/2014; Pedigree: W003648, EXP: 6/25/2014; Pedigree: AD60272_40, EXP: 5/22/2014.