RAMIPRIL
Generic: RAMIPRIL
Rising Pharma HoldingsManufacturer
ORALRoute
RAMIPRILActive Substance
2011-06-08Original Approval
RAMIPRIL is FDA application ANDA091604, 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 II2024-10-23
Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II2026-08-24
Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottFailed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohex
Class II2024-10-23
Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 6818CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II2024-10-23
Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Top Reported Reactions
1
DYSPNOEA
8,357 reports
2
FATIGUE
8,164 reports
3
NAUSEA
7,571 reports
4
DIARRHOEA
7,184 reports
5
OFF LABEL USE
6,830 reports
6
DIZZINESS
6,764 reports
7
DRUG INEFFECTIVE
6,584 reports
8
VOMITING
6,310 reports
9
PAIN
5,928 reports
10
HEADACHE
5,628 reports