Drug Enforcement D-581-2014

Labeling: Label Mixup; LACTOBACILLUS GG Capsule, 15 Billion Cells may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: W003356, EXP: 6/19/2014; ZONISAMIDE, Capsule, 100 mg, NDC 64679099001, Pedigree: W003786, EXP: 6/27/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: W003860, EXP: 6/27/2014.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
LACTOBACILLUS GG Capsule, 15 Billion Cells, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49100036374
Product quantity
630 Cells
Reason for recall
Labeling: Label Mixup; LACTOBACILLUS GG Capsule, 15 Billion Cells may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: W003356, EXP: 6/19/2014; ZONISAMIDE, Capsule, 100 mg, NDC 64679099001, Pedigree: W003786, EXP: 6/27/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: W003860, EXP: 6/27/2014.
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-581-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
LACTOBACILLUS GG, Capsule, 15 Billion Cells has the following codes Pedigree: W003357, EXP: 6/19/2014; Pedigree: W003787, EXP: 6/27/2014; Pedigree: W003869, EXP: 6/27/2014.
More code info