NALOXONE HYDROCHLORIDE

Generic: NALOXONE HYDROCHLORIDE

BPI Labs LLCManufacturer
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSRoute
NALOXONE HYDROCHLORIDEActive Substance
2023-10-06Original Approval

NALOXONE HYDROCHLORIDE is FDA application ANDA216977, sponsored by BPI LABS. 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 I2018-06-04
Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit (ND

Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.

Top Reported Reactions

1
TOXICITY TO VARIOUS AGENTS
780 reports
2
DRUG INEFFECTIVE
570 reports
3
OVERDOSE
462 reports
4
OFF LABEL USE
344 reports
5
NAUSEA
312 reports
6
VOMITING
259 reports
7
DEATH
251 reports
8
ACUTE KIDNEY INJURY
233 reports
9
PAIN
231 reports
10
DRUG ABUSE
221 reports