PlainRecalls
FDA Drug Low Class III Terminated

Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0512-01, 81 Count NDC: 0135-0512-02, 108 Count NDC: 0135-0512-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-663-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilm

Reported: April 30, 2014 Initiated: February 20, 2014 #D-1238-2014

Product Description

Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0512-01, 81 Count NDC: 0135-0512-02, 108 Count NDC: 0135-0512-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-663-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0446-01.

Reason for Recall

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

Details

Units Affected
109,848 72 Ct Vials, 61,332 81 Ct Vials, 16,218 108 Ct Vials
Distribution
U.S. Nationwide
Location
Aiken, SC

Frequently Asked Questions

What product was recalled?
Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0512-01, 81 Count NDC: 0135-0512-02, 108 Count NDC: 0135-0512-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-663-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0446-01.. Recalled by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline. Units affected: 109,848 72 Ct Vials, 61,332 81 Ct Vials, 16,218 108 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-1238-2014.