GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline recalls Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labe
Recalled April 30, 2014 · FDA recall D-1240-2014 · GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Hazard
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. · FDA Class III
Units
603,696 72 Ct Vials, 191,040 108 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, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0511-01,108 Count NDC: 0135-0515-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-862-01 and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0209-01, 108 Count NDC: 0363-0209-07.
Manufacturer(s)
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →