FDA Drug recall D-1240-2014
Nicotine polacrilex lozenge, 4 mg, Original 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, Original 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-1240-2014 |
| 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, Original 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: 0135-0511-01,108 Count NDC: 0135-0515-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-862-01 and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0209-01, 108 Count NDC: 0363-0209-07.
Reason
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Identifiers
| ndc | 0135-0510-01 |
|---|---|
| ndc | 0135-0510-06 |
| ndc | 0135-0510-07 |
| ndc | 0135-0511-01 |
| ndc | 0135-0511-06 |
| ndc | 0135-0511-07 |
| ndc | 0135-0515-03 |
| ndc | 30142-862-01 |
| ndc | 0363-0209-01 |
| ndc | 0363-0209-07 |
| code_info | Labeled A) 72 Ct Vial: Lot # 13434 (exp 4/14), 13546 (exp 5/14), 13907 (exp 11/14), 14020 (exp 1/15), 14107 (exp 3/15),…Labeled A) 72 Ct Vial: 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, 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; Lot # 13924 (exp 12/14),13975 (exp 12/14),14434 (exp 10/15). Labeled C) 72 Ct Vials, Lot #13614 (exp 7/14), 13790 (exp 10/14), 13889 (exp 11/14) & 14018 (exp 12/14), Lot # 13683 (4/17) & 13862 (11/14), 108 Ct Vial, Lot #13726 (exp 10/14) & 13779 (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-1240-2014%22
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