FDA-Drug2014-04-30Class III

Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination. Contains 30 Pieces/ Pallet. OTC only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1442-81-2.

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
12,162 Pallets
Manufactured in
65 Windham Blvd, N/A, Aiken, SC, United States
Products
Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination. Contains 30 Pieces/ Pallet. OTC only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1442-81-2.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1244-2014

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