FDA-Drug2014-04-30Class III
Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0513-01, 81 Count NDC: 0135-0513-02, 108 Count NDC: 0135-0513-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-664-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 20
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Hazard
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Sold states
U.S. Nationwide
Affected count
304,332 72 Ct Vials, 85,080 81 Ct Vials 22,992 108 Ct Vials
Manufactured in
65 Windham Blvd, N/A, Aiken, SC, United States
Products
Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0513-01, 81 Count NDC: 0135-0513-02, 108 Count NDC: 0135-0513-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-664-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-9200-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1239-2014Don't want to check this manually?
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