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.
Recall Number: D-1243-2014
Firm: GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Classification: Class III
Status: Terminated
Report Date: 20140430
Initiation Date: 20140220
Termination Date: 20170120
Reason for Recall
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Product Description
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.