Home / Recalls / GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline / D-1246-2014

D-1246-2014 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
189,900 20 ct Vials, 145,068 81 ct Vials

Product Description

Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0509-04, 81 Count NDC: 0135-0509-02.

Reason for Recall

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

Distribution Pattern

U.S. Nationwide

Code Information

(20 ct) Lot #14337 (exp 7/15), 14398 (exp 9/15) & 14510 (exp 9/15); (81 ct) Lot #14336 (exp 7/15), 14347 (exp 7/15), 14378 (9/15), 14563 (exp 9/15)

Other recalls by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

  • 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-1244-2014 Class III — Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combinati (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)