Drug Enforcement D-579-2014

Labeling: Label Mixup; LACTOBACILLUS GG Capsule may be potentially mislabeled as VITAMIN B COMPLEX W/C, Capsule, NDC 54629008001, Pedigree: AD39560_4, EXP: 5/13/2014; DOCUSATE SODIUM, Capsule, 50 mg, NDC 67618010060, Pedigree: AD65457_13, EXP: 5/24/2014; VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC 60258016001, Pedigree: AD70655_17, EXP: 5/28/2014; TACROLIMUS, Capsule, 1 mg, NDC 00781210

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
LACTOBACILLUS GG Capsule, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49100036374
Product quantity
1,970 Capsules
Reason for recall
Labeling: Label Mixup; LACTOBACILLUS GG Capsule may be potentially mislabeled as VITAMIN B COMPLEX W/C, Capsule, NDC 54629008001, Pedigree: AD39560_4, EXP: 5/13/2014; DOCUSATE SODIUM, Capsule, 50 mg, NDC 67618010060, Pedigree: AD65457_13, EXP: 5/24/2014; VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC 60258016001, Pedigree: AD70655_17, EXP: 5/28/2014; TACROLIMUS, Capsule, 1 mg, NDC 00781210
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-579-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
LACTOBACILLUS GG, Capsule has the following codes Pedigree: AD39588_4, EXP: 5/13/2014 Pedigree: AD65457_16, EXP: 5/24/2014 Pedigree: AD70655_8, EXP: 5/29/2014 Pedigree: AD73627_17, EXP: 5/30/2014 Pedigree: W003051, EXP: 6/12/2014 Pedigree: W003216, EXP: 6/14/2014 Pedigree: AD42584_12, EXP: 5/14/2014 Pedigree: AD46300_11, EXP: 5/15/2014 Pedigree: W002968, EXP: 6/11/2014 Pedigree: AD68019_1, EXP: 5/28/2014 Pedigree: W003172, EXP: 6/13/2014 Pedigree: W003173, EXP: 6/13/2014
More code info