PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 29, 2014 Initiated: July 2, 2013 #D-803-2014

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
Aidapak Services, LLC
Units Affected
168 Tablets
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Location
Vancouver, WA

Frequently Asked Questions

What product was recalled?
VARENICLINE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00069046856.. Recalled by Aidapak Services, LLC. Units affected: 168 Tablets.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 29, 2014. Severity: Moderate. Recall number: D-803-2014.