FDA recall D-1246-2014

Product

Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0509-04, 81 Count NDC: 0135-0509-02.

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-1246-2014