FDA-Drug2014-04-30Class III
Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0510-05, 189 Count NDC: 0135-0510-03.
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
147,684 81 Ct Vials, 130564 189 Ct Vials
Manufactured in
65 Windham Blvd, N/A, Aiken, SC, United States
Products
Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0510-05, 189 Count NDC: 0135-0510-03.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1242-2014Don't want to check this manually?
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