NICORETTE ORIGINAL
Generic: NICOTINE POLACRILEX
Haleon US Holdings LLCManufacturer
ORALRoute
NICOTINEActive Substance
1984-01-13Original Approval
NICORETTE ORIGINAL is FDA application NDA018612, sponsored by HALEON US HOLDINGS. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class III2014-02-20
Nicotine polacrilex lozenge, 2 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. LabeFailed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III2014-02-20
Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge Vials, OTC. Distributed Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III2014-02-20
Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. LabeFailed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III2014-02-20
Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 LozengeFailed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Top Reported Reactions
1
DRUG INEFFECTIVE
4,747 reports
2
NICOTINE DEPENDENCE
4,054 reports
3
INTENTIONAL DRUG MISUSE
3,435 reports
4
NAUSEA
2,800 reports
5
MALAISE
1,466 reports
6
HEADACHE
1,239 reports
7
DIZZINESS
1,234 reports
8
DRUG ADMINISTRATION ERROR
1,176 reports
9
OVERDOSE
1,121 reports
10
VOMITING
1,040 reports