ZOLPIDEM TARTRATE
Generic: ZOLPIDEM TARTRATE
Sandoz IncManufacturer
ORALRoute
ZOLPIDEM TARTRATEActive Substance
2011-07-01Original Approval
ZOLPIDEM TARTRATE is FDA application ANDA090107, sponsored by SANDOZ. 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 II2024-01-18
Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun PharmaceutiCGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufactu
Class II2024-01-18
Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun PharmaceutCGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufactu
Top Reported Reactions
1
DRUG INEFFECTIVE
1,429 reports
2
NAUSEA
1,224 reports
3
FATIGUE
1,155 reports
4
INSOMNIA
980 reports
5
DIARRHOEA
915 reports
6
FALL
912 reports
7
HEADACHE
895 reports
8
COMPLETED SUICIDE
882 reports
9
VOMITING
798 reports
10
PAIN
797 reports