FDA Drug recall D-1239-2014
Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count cartons, and 108 count cartons
- FDA Drug
- Class III
- terminated
- Published 2014-04-30
On 2014-04-30 the FDA classified a Class III recall of Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count cartons, and 108 count cartons by Glaxosmithkline Consumer Healthcare Dba Glaxosmithkline, citing failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1239-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-02-20 |
| Published | 2014-04-30 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Glaxosmithkline Consumer Healthcare Dba Glaxosmithkline |
| Distribution | US |
Product
Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0513-01, 81 Count NDC: 0135-0513-02, 108 Count NDC: 0135-0513-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-664-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-9200-01.
Reason
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Identifiers
| code_info | Labeled A) 72 Ct Vial, Lot # 13481 (exp 5/14), 13674 (exp 5/14), 14056 (exp 2/15), 14092 (exp 3/15), 14258 (exp 7/15),…Labeled A) 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 B) 72 Ct Vial, Lot # 14041 (exp 2/15), 14117 (exp 2/15) & 14268 (exp 4/15); Labeled C) 72 Ct Vial Lot #13671 (exp 8/14) & 13890 (exp 11/14). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1239-2014%22
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