Reported Apr 30, 2014 · Terminated
Nicotine polacrilex lozenge, 4 mg, Cherry 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
Is this the product you have?
- Nicotine polacrilex lozenge, 4 mg, Cherry 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
0135-0513-0181
- Count NDC
0135-0513-02108
- Count NDC0135-0513-03 b. Nicotine Lozenge Kroger
- Distributed byThe Kroger Company, Cincinnati, Ohio 45202, 72
- Count NDC30142-664-01, and c. Nicotine Walgreens
- Distributed byWalgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72
- Count NDC0363-9200-01
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 72 Ct Vial, Lot # 13481 (exp 5/14), 13674 (exp 5/14), 14056 (exp 2/15), 14092 (exp 3/15), 14258 (exp 7/15), 14450 (exp 10/15); 81 Ct Vial, Lot # 13855 (exp 1/15), 13927 (exp 10/14) & 14093 (exp 3/15); 108 Ct Vial, Lot # 13643 (exp 8/14) & 13992 (exp 12/14). Labeled 2 72 Ct Vial, Lot # 14041 (exp 2/15), 14117 (exp 2/15) & 14268 (exp 4/15); Labeled 3 72 Ct Vial Lot #13671 (exp 8/14) & 13890 (exp 11/14). - Amount recalled
- 304,332 72 Ct Vials, 85,080 81 Ct Vials 22,992 108 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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