ENALAPRIL MALEATE
Generic: ENALAPRIL MALEATE
Rising Pharma HoldingsManufacturer
ORALRoute
ENALAPRIL MALEATEActive Substance
2024-09-19Original Approval
ENALAPRIL MALEATE is FDA application ANDA218531, sponsored by UNIQUE PHARM. 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 II2022-03-16
Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufactured by Taro Pharmaceutical Industries, LtCGMP Deviations
Class II2022-03-16
Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufactured by Taro Pharmaceutical Industries, LtdCGMP Deviations
Class II2022-03-16
Enalapril Maleate Tablets, USP; 5 mg; 90 tablets, NDC 60429-184-90; manufactured by Taro Pharmaceutical Industries, Ltd.CGMP Deviations
Class II2026-04-23
Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurit
Class II2022-03-16
Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufactured by Taro Pharmaceutical Industries, LtdCGMP Deviations
Top Reported Reactions
1
DIARRHOEA
2,907 reports
2
DYSPNOEA
2,721 reports
3
NAUSEA
2,638 reports
4
DRUG INEFFECTIVE
2,611 reports
5
FATIGUE
2,441 reports
6
DRUG INTERACTION
2,420 reports
7
DIZZINESS
2,278 reports
8
ACUTE KIDNEY INJURY
2,090 reports
9
VOMITING
2,033 reports
10
HEADACHE
1,869 reports