FDA Drug recall D-1243-2014
Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials
- 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, Mint Flavor, 81 Lozenge and 189 Lozenge Vials 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-1243-2014 |
| 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, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0511-05, 189 Count NDC: 0135-0511-03.
Reason
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Identifiers
| code_info | 81 Ct Vial Lot # 13728 (exp 8/14), 13771 (exp 10/14), 13993 (exp 1/15) & 13994 (exp 1/15); 189 Ct Vial Lot # 12H23N (e…81 Ct Vial Lot # 13728 (exp 8/14), 13771 (exp 10/14), 13993 (exp 1/15) & 13994 (exp 1/15); 189 Ct Vial Lot # 12H23N (exp 5/14), 12K02N (exp 6/14), 12K06N (exp 10/14), 12K30N (exp 10/14), 12L04N (exp 10/14), 12L04N1 (exp 10/14), 13A08N (exp 10/14), 13B08N (exp 1/15), 13D02N (2/15), 13E01N (exp 3/15), 13E21N (exp 4/15), 13G18N (exp 5/15), 13H06N (exp 5/15), 13H07N (exp 7/15), 13H30N (exp 7/15), 13H30NN (exp 7/15), 13I25N (exp 7/15), 13I26N (exp 8/15) & 13K27N (exp 8/15). |
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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-1243-2014%22
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