GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline recalls Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge
Recalled April 30, 2014 · FDA recall D-1245-2014 · GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Hazard
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. · FDA Class III
Units
834,072 81 ct Vials, 414,500 20 ct Vials, 9456 135 ct Vials
Sold at
U.S. Nationwide
Description
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Product
Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0508-04, 27 Count NDC: 0135-0508-03, 81 Count NDC: 0135-0508-02, 135 Count NDC: 0125-0508-03.
Manufacturer(s)
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →