NALBUPHINE HYDROCHLORIDE

Generic: NALBUPHINE HYDROCHLORIDE

Somerset TherapeuticsManufacturer
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSRoute
NALBUPHINE HYDROCHLORIDEActive Substance
2024-09-19Original Approval

NALBUPHINE HYDROCHLORIDE is FDA application ANDA216049, sponsored by SOMERSET THERAPS LLC. 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 II2012-11-21
Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC

Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missin

Top Reported Reactions

1
DRUG HYPERSENSITIVITY
36 reports
2
OFF LABEL USE
16 reports
3
DRUG INEFFECTIVE
11 reports
4
FOETAL EXPOSURE DURING PREGNANCY
10 reports
5
NEONATAL ASPHYXIA
10 reports
6
NEONATAL EPILEPTIC SEIZURE
10 reports
7
MALAISE
7 reports
8
PAIN
7 reports
9
PANCREATITIS ACUTE
7 reports
10
VOMITING
7 reports