FDA Drug Low Class III Terminated

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.

Reported: April 30, 2014 Initiated: February 20, 2014 #D-1243-2014

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: 146,424 81 Ct. Vials, 105,091 189 Ct Vials
Distribution: U.S. Nationwide
Location: Aiken, SC

Frequently Asked Questions

What product was recalled? ▼

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.. Recalled by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline. Units affected: 146,424 81 Ct. Vials, 105,091 189 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-1243-2014.