ROPIVACAINE HYDROCHLORIDE

Generic: ROPIVACAINE HYDROCHLORIDE

Caplin Steriles LimitedManufacturer
EPIDURAL, INFILTRATION, PERINEURALRoute
ROPIVACAINE HYDROCHLORIDEActive Substance
2020-04-09Original Approval

ROPIVACAINE HYDROCHLORIDE is FDA application ANDA212808, sponsored by CAPLIN. 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 I2025-04-17
Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt.

Presence of Particulate Matter

Top Reported Reactions

1
VOMITING
557 reports
2
DRUG HYPERSENSITIVITY
549 reports
3
PNEUMONIA
544 reports
4
OEDEMA
543 reports
5
DYSPNOEA
537 reports
6
ASTHMA
525 reports
7
WHEEZING
513 reports
8
PAIN
229 reports
9
MALAISE
213 reports
10
RESPIRATORY TRACT INFECTION
202 reports