GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline recalls Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By
Recalled April 30, 2014 · FDA recall D-1243-2014 · GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Hazard
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. · FDA Class III
Units
146,424 81 Ct. Vials, 105,091 189 Ct Vials
Sold at
U.S. Nationwide
Description
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Product
Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0511-05, 189 Count NDC: 0135-0511-03.
Manufacturer(s)
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →