Reported Apr 30, 2014 · Terminated
Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials. OTC. Labeled a.…
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
Is this the product you have?
- Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials. OTC. Labeled a. Nicorette
- Distributed ByGlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72
- Count NDC
0135-0512-0181
- Count NDC
0135-0512-02108
- Count NDC0135-0512-03 b. Nicotine Lozenge Kroger
- Distributed byThe Kroger Company, Cincinnati, Ohio 45202, 72
- Count NDC30142-663-01, and c. Nicotine Walgreens
- Distributed byWalgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72
- Count NDC0363-0446-01
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 Lot #13468 (exp 4/14), 13618 (exp 6/14) & 14105 (exp 2/15); 81 Ct- Vial 2 Lot #13815 (exp 10/14), 13864 (exp 11/14) & 13941 (exp 12/14); 108 Ct- Vial 3 Lot # 13574 (exp 7/14). Labeled B) 72 Ct Vial 4 Lot #13573 (exp 6/14) & 14257 (exp 7/15). Labeled C) 72 Ct Vial 5 Lot # 13875 (exp 5/14), 13642 (exp 7/14), 13770 (exp 8/14) & 13875 (exp 11/14). - Amount recalled
- 109,848 72 Ct Vials, 61,332 81 Ct Vials, 16,218 108 Ct Vials
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
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