EQUATE NICOTINE
Generic: NICOTINE POLACRILEX
Wal-Mart Stores IncManufacturer
ORALRoute
NICOTINEActive Substance
2006-10-30Original Approval
EQUATE NICOTINE is FDA application ANDA078326, sponsored by PERRIGO R AND D. 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 III2014-08-19
Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. Perrigo, 502 Eastern Ave, Plant #6, AllegaFailed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test
Class III2026-05-14
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IFailed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, excee
Top Reported Reactions
1
DRUG INEFFECTIVE
3,094 reports
2
NAUSEA
1,828 reports
3
NICOTINE DEPENDENCE
1,462 reports
4
HEADACHE
997 reports
5
PRODUCT ADHESION ISSUE
945 reports
6
DIZZINESS
895 reports
7
OVERDOSE
871 reports
8
MALAISE
862 reports
9
MACULAR DEGENERATION
796 reports
10
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS
784 reports