CLOPIDOGREL
Generic: CLOPIDOGREL BISULFATE
Aurobindo Pharma LimitedManufacturer
ORALRoute
CLOPIDOGREL BISULFATEActive Substance
2012-05-17Original Approval
CLOPIDOGREL is FDA application ANDA090540, sponsored by AUROBINDO PHARMA LTD. 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 II2021-08-02
Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ Presence of foreign matter
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
5,392 reports
2
FATIGUE
4,761 reports
3
DIZZINESS
4,168 reports
4
DIARRHOEA
4,074 reports
5
DRUG INEFFECTIVE
4,036 reports
6
NAUSEA
3,902 reports
7
ANAEMIA
3,730 reports
8
DRUG INTERACTION
3,666 reports
9
FALL
3,608 reports
10
MYOCARDIAL INFARCTION
3,482 reports