BUTORPHANOL TARTRATE

Generic: BUTORPHANOL TARTRATE

Apotex Corp.Manufacturer
NASALRoute
BUTORPHANOL TARTRATEActive Substance
2002-12-04Original Approval

BUTORPHANOL TARTRATE is FDA application ANDA075499, sponsored by APOTEX. 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 II2021-03-15
Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles Rx Only NDC 60505-0813-1 Mfg by: Apotex Inc. Toronto, O

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Top Reported Reactions

1
DRUG HYPERSENSITIVITY
48 reports
2
DRUG INEFFECTIVE
45 reports
3
PRODUCT DOSE OMISSION ISSUE
38 reports
4
NAUSEA
25 reports
5
HEADACHE
17 reports
6
PRURITUS
17 reports
7
PAIN
16 reports
8
VOMITING
16 reports
9
ANXIETY
14 reports
10
DYSPNOEA
14 reports