Reported Apr 30, 2014 · Terminated

Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC.…

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, 4 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette
Distributed ByGlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72
Count NDC
- 0135-0511-01
- 108
Count NDC0135-0515-03, b. Nicotine Lozenge Kroger, Lozenge Kroger
Distributed byThe Kroger Company, Cincinnati, Ohio 45202, 72
Count NDC30142-862-01 and c. Nicotine Walgreens
Distributed byWalgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72
Count NDC
- 0363-0209-01
- 108
Count NDC0363-0209-07

Lot codes and dates: 6 of 6 products
Products covered by this recall
# Product as published
1 Lot # 13434 (exp 4/14), 13546 (exp 5/14), 13907 (exp 11/14), 14020 (exp 1/15), 14107 (exp 3/15), 14183 (exp 4/15), 14273 (exp 7/15), 14335 (exp 8/15), & 14421 (exp 9/15), 12F27N (exp 4/14), 12K01N (exp 5/14), 13A25N (exp 11/14) & 13C18N (exp 1/15); 108 Ct Vial
2 Lot # 13383 (exp 4/14), 13626 (exp 5/14), 13725 (exp 10/14), 13861 (exp 12/14), 13980 (exp 1/15), 13982 (exp 1/15), 14091 (exp 4/15), 14153 (exp 5/15), 14227 (exp 7/15), 14262 (exp 7/15), 14318 (exp 8/15), 14371 (exp 8/15) & 14458 (exp 10/15). Labeled B) 72 Ct Vial
3 Lot # 13924 (exp 12/14),13975 (exp 12/14),14434 (exp 10/15). Labeled C) 72 Ct Vials
4 Lot #13614 (exp 7/14), 13790 (exp 10/14), 13889 (exp 11/14) & 14018 (exp 12/14)
5 Lot # 13683 (4/17) & 13862 (11/14), 108 Ct Vial
6 Lot #13726 (exp 10/14) & 13779 (exp 11/14).
Amount recalled: 603,696 72 Ct Vials, 191,040 108 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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#	Product as published
1	Lot # 13434 (exp 4/14), 13546 (exp 5/14), 13907 (exp 11/14), 14020 (exp 1/15), 14107 (exp 3/15), 14183 (exp 4/15), 14273 (exp 7/15), 14335 (exp 8/15), & 14421 (exp 9/15), 12F27N (exp 4/14), 12K01N (exp 5/14), 13A25N (exp 11/14) & 13C18N (exp 1/15); 108 Ct Vial
2	Lot # 13383 (exp 4/14), 13626 (exp 5/14), 13725 (exp 10/14), 13861 (exp 12/14), 13980 (exp 1/15), 13982 (exp 1/15), 14091 (exp 4/15), 14153 (exp 5/15), 14227 (exp 7/15), 14262 (exp 7/15), 14318 (exp 8/15), 14371 (exp 8/15) & 14458 (exp 10/15). Labeled B) 72 Ct Vial
3	Lot # 13924 (exp 12/14),13975 (exp 12/14),14434 (exp 10/15). Labeled C) 72 Ct Vials
4	Lot #13614 (exp 7/14), 13790 (exp 10/14), 13889 (exp 11/14) & 14018 (exp 12/14)
5	Lot # 13683 (4/17) & 13862 (11/14), 108 Ct Vial
6	Lot #13726 (exp 10/14) & 13779 (exp 11/14).