LURASIDONE HYDROCHLORIDE
Generic: LURASIDONE HYDROCHLORIDE
Accord HealthcareManufacturer
ORALRoute
LURASIDONE HYDROCHLORIDEActive Substance
2019-01-03Original Approval
LURASIDONE HYDROCHLORIDE is FDA application ANDA208049, sponsored by ACCORD HLTHCARE. 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
Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, ICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufactu
Class II2024-01-18
Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufactu
Top Reported Reactions
1
DRUG INEFFECTIVE
353 reports
2
SUICIDE ATTEMPT
242 reports
3
CONDITION AGGRAVATED
166 reports
4
SEDATION
152 reports
5
DYSKINESIA
151 reports
6
DYSTONIA
142 reports
7
ANOSOGNOSIA
139 reports
8
BLOOD PROLACTIN ABNORMAL
139 reports
9
SEXUAL DYSFUNCTION
139 reports
10
BLOOD GLUCOSE INCREASED
137 reports