Drug recall D-1246-2014

Class III Terminated reported Apr 30, 2014

Product

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.

Lots and codes

(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)

Recall details

Recalling firm
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline, Aiken, SC
Quantity
189,900 20 ct Vials, 145,068 81 ct Vials
Distribution
U.S. Nationwide
Type
Voluntary: Firm initiated
Recall initiated
February 20, 2014
Terminated
January 20, 2017

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