Home / Recalls / GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline / D-1244-2014

D-1244-2014 Class III Terminated

Recalled by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline — Aiken, SC

Recall Details

Product Type
Drugs
Report Date
April 30, 2014
Initiation Date
February 20, 2014
Termination Date
January 20, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12,162 Pallets

Product Description

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.

Reason for Recall

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

Distribution Pattern

U.S. Nationwide

Code Information

Lot #12K16W (exp 5/14), 12K27N (exp 6/14), 12K27W (exp 6/14), 12K29N (exp 6/14), 13K20W (exp 6/15), 13K20W1 (exp 6/15) & 13K25N (exp 6/15).

Other recalls by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

  • D-1246-2014 Class III — Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge (February 20, 2014)
  • D-1245-2014 Class III — Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge (February 20, 2014)
  • D-1242-2014 Class III — Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count c (February 20, 2014)
  • D-1243-2014 Class III — Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials (February 20, 2014)
  • D-1240-2014 Class III — Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 count c (February 20, 2014)
  • D-1247-2014 Class III — Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint Flav (February 20, 2014)
  • D-1241-2014 Class III — Nicotine polacrilex lozenge, 2 mg, Original Flavor, 72 count cartons, 81 count c (February 20, 2014)
  • D-1238-2014 Class III — Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials (February 20, 2014)
  • D-1239-2014 Class III — Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count car (February 20, 2014)