FDA recall D-1245-2014

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline · Class III · drug

Product

Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0508-04, 27 Count NDC: 0135-0508-03, 81 Count NDC: 0135-0508-02, 135 Count NDC: 0125-0508-03.

Reason for recall

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

Distribution

U.S. Nationwide

Key facts

Status: Terminated
Initiation date: 2014-02-20
Report date: 2014-04-30
Termination date: 2017-01-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Aiken, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1245-2014