VARENICLINE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00069046856.

Recall Number: D-803-2014

Firm: Aidapak Services, LLC

Classification: Class II

Status: Terminated

Report Date: 20140129

Initiation Date: 20130702

Termination Date: 20140207

Labeling: Label Mixup: VARENICLINE, Tablet, 0.5 mg may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS GG, Capsule, 0, NDC 49100036374, Pedigree: W003051, EXP: 6/12/2014; SOTALOL HCL, Tablet, 160 mg, NDC 00093106201, Pedigree: AD22609_10, EXP: 4/30/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: AD62796_4, EXP: 5/22/2014.

VARENICLINE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00069046856.