Reported Apr 30, 2014 · Terminated

Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette,…

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline · 65 Windham Blvd · Aiken, SC · 29805-9384

Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette
Distributed ByGlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81
Count NDC
- 0135-0510-05
- 189
Count NDC0135-0510-03

Lot codes and dates: 81 Ct Vial
Lot # 13727 (exp 8/14)
13816 (exp 10/14)
& 13965 (exp 12/14)
189 Ct Vial
Lot # 12H17N (exp 4/14)
12H20N (exp 6/14)
12J16N (exp 6/14)
12K03N (exp 9/14)
12L05N (exp 10/14)
12L07N (exp 9/14)
12L17N (exp 10/14)
13A04N (exp 11/14)
13A23N (exp 11/14)
13C04N (exp 1/15)
13C08N (exp 1/15)
13D17N (exp 11/14)
13D18N (exp 1/15)
13D18N1 (exp 3/15)
13E24N (exp 4/15)
13E28N (exp 4/15)
13G16N (exp 4/15)
13G17N (exp 5/14)
13H02N (exp 5/15)
13H22N (exp 5/15)
13I18N (exp 8/15)
13I20N (exp 5/15)
13J24N (exp 8/15)
13J24N1 (exp 9/15)
13K08N (exp 8/15)
13K11N (exp 9/15)
13L11N (exp 10/15) & 13L11N1 (exp 10/15)
Amount recalled: 147,684 81 Ct Vials, 130564 189 Ct Vials

The agency filed one notice per product. You are reading one of them; the other 9 are below.

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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