CLOPIDOGREL BISULFATE
Generic: CLOPIDOGREL BISULFATE, CLOPIDOGREL
RADHA PHARMACEUTICALSManufacturer
ORALRoute
CLOPIDOGREL BISULFATEActive Substance
2014-09-15Original Approval
CLOPIDOGREL BISULFATE is FDA application ANDA204165, sponsored by SCIEGEN PHARMS. 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 II2018-11-07
Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's LaboratoFailed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th
Class II2018-12-10
Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's LaboratoFailed dissolution specification -Two additional lots being recalled due to Out-of-Specification res
Top Reported Reactions
1
DYSPNOEA
909 reports
2
FATIGUE
809 reports
3
MYOCARDIAL INFARCTION
797 reports
4
DRUG INEFFECTIVE
713 reports
5
NAUSEA
675 reports
6
DIZZINESS
665 reports
7
DIARRHOEA
657 reports
8
ANAEMIA
637 reports
9
ASTHENIA
617 reports
10
OFF LABEL USE
590 reports