ROPINIROLE HYDROCHLORIDE

Generic: ROPINIROLE HYDROCHLORIDE

SOLCO HEALTHCARE USManufacturer
ORALRoute
ROPINIROLE HYDROCHLORIDEActive Substance
2008-05-05Original Approval

ROPINIROLE HYDROCHLORIDE is FDA application ANDA078110, sponsored by PRINSTON INC. 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 II2023-02-07
rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703

CGMP Deviations: recalling drug products following an FDA inspection.

Class II2023-02-07
rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Ma

CGMP Deviations: recalling drug products following an FDA inspection.

Class II2023-02-07
rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manu

CGMP Deviations: recalling drug products following an FDA inspection.

Class II2023-02-07
rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Man

CGMP Deviations: recalling drug products following an FDA inspection.

Class II2023-02-07
rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Man

CGMP Deviations: recalling drug products following an FDA inspection.

Class II2023-02-07
rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manu

CGMP Deviations: recalling drug products following an FDA inspection.

Class II2023-02-07
rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 M

CGMP Deviations: recalling drug products following an FDA inspection.

Top Reported Reactions

1
DRUG INEFFECTIVE
1,424 reports
2
FALL
1,253 reports
3
FATIGUE
1,193 reports
4
NAUSEA
1,149 reports
5
DIZZINESS
908 reports
6
HALLUCINATION
886 reports
7
PAIN
793 reports
8
DYSPNOEA
789 reports
9
DIARRHOEA
767 reports
10
DEATH
762 reports