Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0510-05, 189 Count NDC: 0135-0510-03.

Recall Number: D-1242-2014

Firm: GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Classification: Class III

Status: Terminated

Report Date: 20140430

Initiation Date: 20140220

Termination Date: 20170120

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0510-05, 189 Count NDC: 0135-0510-03.