FDA Drug recall D-1241-2014
Nicotine polacrilex lozenge, 2 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, 2 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-1241-2014 |
| 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, 2 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: 0135-0510-01,108 Count NDC: 0135-0514-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC: 30142-861-01. c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 108 Count NDC: 0363-0208-07.
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 | 0135-0514-03 |
| ndc | 30142-861-01 |
| ndc | 0363-0208-07 |
| code_info | Labeled A) 72 Count Vial, Lot # 13404 (exp 4/14),13499 (exp 5/14), 13549 (exp 6/14), 14004 (exp 1/15), 14079 (exp 2/15)…Labeled A) 72 Count Vial, Lot # 13404 (exp 4/14),13499 (exp 5/14), 13549 (exp 6/14), 14004 (exp 1/15), 14079 (exp 2/15), 14178 (exp 5/15), 14297 (exp 7/15) & 14425 (exp 9/15); 108 Ct Vial: Lot # 13449 (exp 5/14), 13657 (exp 8/14), 13723 (exp 8/14), 13781 (exp 11/14), 13867 (exp 11/14), 13897 (exp 12/14), 13960 (exp 1/15), 13981 (exp 12/14), 14016 (exp 2/15), 14254 (exp 7/15), 14305 (exp 7/15), 14341 (exp 7/15), 14370 (exp 8/15) & 14465 (exp 11/15). Labeled B) 72 Count Vial, Lot #13417 (exp 5/14), 13570 (exp 6/14), 13974 (exp 1/15), 14089 (exp 2/15), 14225 (exp 5/15), 14269 (exp 7/15), 14311 (exp 7/15) & 14396 (exp 8/15).Labeled C) 108 Ct Vial: Lot #:13656 (exp 8/14), 13753 (exp 9/14). |
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-1241-2014%22
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