KIRKLAND SIGNATURE NICOTINE

Generic: NICOTINE, NICOTINE POLACRILEX

Costco Wholesale CompanyManufacturer
ORALRoute
NICOTINEActive Substance
2009-07-10Original Approval

KIRKLAND SIGNATURE NICOTINE is FDA application ANDA090711, sponsored by PPI-DAC. 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, Allega

Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test

Top Reported Reactions

1
DRUG INEFFECTIVE
1,642 reports
2
NAUSEA
821 reports
3
NICOTINE DEPENDENCE
657 reports
4
MACULAR DEGENERATION
567 reports
5
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS
452 reports
6
MALAISE
336 reports
7
ORAL DISCOMFORT
334 reports
8
DYSPEPSIA
318 reports
9
INTENTIONAL DRUG MISUSE
293 reports
10
HEADACHE
290 reports