Nicotine polacrilex lozenge, 2 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: 0135-0510-01,108 Count NDC: 0135-0514-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC: 30142-861-01. c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 108 Count NDC: 0363-0208-07.

Recall Number: D-1241-2014

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, 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: 0135-0510-01,108 Count NDC: 0135-0514-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC: 30142-861-01. c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 108 Count NDC: 0363-0208-07.