CLOZAPINE
Generic: CLOZAPINE
Aurobindo Pharma LimitedManufacturer
ORALRoute
CLOZAPINEActive Substance
2016-11-29Original Approval
CLOZAPINE is FDA application ANDA206433, sponsored by AUROBINDO PHARMA. 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 II2020-06-12
Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 PrincetonPresence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count
Class II2018-09-21
Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North WaleFailed Disintegration Specifications: Out-of-specification disintegration test result obtained durin
Top Reported Reactions
1
NEUTROPENIA
16,519 reports
2
HOSPITALISATION
7,690 reports
3
DEATH
5,362 reports
4
DRUG INEFFECTIVE
3,126 reports
5
DRUG INTERACTION
2,783 reports
6
GRANULOCYTOPENIA
2,567 reports
7
OFF LABEL USE
2,113 reports
8
PSYCHOTIC DISORDER
1,877 reports
9
LEUKOPENIA
1,738 reports
10
NEUTROPHILIA
1,685 reports