Recall: D-1246-2014

Class III - Minor Violations

Class IIIClassification

2014-02-20Initiated

TerminatedStatus

GlaxoSmithKline Consumer HealtFirm

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

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

Distribution

U.S. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.