Drug Enforcement D-667-2014

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:

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
RANOLAZINE ER Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 61958100301
Product quantity
840 Tablets
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:
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
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Codes & Dates

Recall number
D-667-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
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.
More code info
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