FDA-Drug2014-01-29Class II

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

Aidapak Services, LLC
Hazard

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.

Sold states
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Affected count
168 Tablets
Manufactured in
14301 Se 1st St, Vancouver, WA, United States
Products
VARENICLINE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00069046856.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-803-2014

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