Drug Enforcement D-697-2014

Labeling: Label Mixup; LUBIPROSTONE Capsule, 24 mcg may be potentially mislabeled as ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD21790_43, EXP: 5/1/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: AD21846_46, EXP: 5/1/2014; VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: AD39858_1, EXP: 5/16/2014.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
LUBIPROSTONE Capsule, 24 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64764024060
Product quantity
180 Capsules
Reason for recall
Labeling: Label Mixup; LUBIPROSTONE Capsule, 24 mcg may be potentially mislabeled as ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD21790_43, EXP: 5/1/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: AD21846_46, EXP: 5/1/2014; VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: AD39858_1, EXP: 5/16/2014.
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-697-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
LUBIPROSTONE Capsule, 24 mcg has the following codes Pedigree: AD21790_46, EXP: 5/1/2014; Pedigree: AD21811_1, EXP: 5/1/2014; Pedigree: AD46312_1, EXP: 5/16/2014.
More code info