FDA Drug Low Class III Terminated

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.

Reported: April 30, 2014 Initiated: February 20, 2014 #D-1246-2014

Product Description

Reason for Recall

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

Details

Recalling Firm: GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Units Affected: 189,900 20 ct Vials, 145,068 81 ct Vials
Distribution: U.S. Nationwide
Location: Aiken, SC

Frequently Asked Questions

What product was recalled? ▼

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.. Recalled by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline. Units affected: 189,900 20 ct Vials, 145,068 81 ct Vials.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on April 30, 2014. Severity: Low. Recall number: D-1246-2014.