GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

FDA Regulatory Profile

Summary

Total Recalls
10
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1246-2014Class IIINicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge VialFebruary 20, 2014
D-1245-2014Class IIINicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 LozFebruary 20, 2014
D-1242-2014Class IIINicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. LabeledFebruary 20, 2014
D-1243-2014Class IIINicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled NicorFebruary 20, 2014
D-1240-2014Class IIINicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 counFebruary 20, 2014
D-1244-2014Class IIINicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination. Contains 30 PieFebruary 20, 2014
D-1247-2014Class IIINicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint Flavored Lozenges + 21 3February 20, 2014
D-1241-2014Class IIINicotine polacrilex lozenge, 2 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 counFebruary 20, 2014
D-1238-2014Class IIINicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vialFebruary 20, 2014
D-1239-2014Class IIINicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count cartons, and 108 count February 20, 2014