SEVOFLURANE
Generic: SEVOFLURANE
Halocarbon Life SciencesManufacturer
RESPIRATORY (INHALATION)Route
SEVOFLURANEActive Substance
2007-11-19Original Approval
SEVOFLURANE is FDA application ANDA078650, sponsored by HALOCARBON PRODS. 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 II2014-04-07
Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manufactured By: Piramal Critical Care, 3950 SchFailed pH Specifications: product was too acidic.
Class II2019-06-13
Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation DeerfieldFailed Stability Specifications
Top Reported Reactions
1
HYPOTENSION
583 reports
2
ANAESTHETIC COMPLICATION NEUROLOGICAL
513 reports
3
DRUG INTERACTION
489 reports
4
CARDIAC ARREST
411 reports
5
BRADYCARDIA
366 reports
6
DRUG INEFFECTIVE
283 reports
7
TACHYCARDIA
264 reports
8
HYPERTHERMIA MALIGNANT
262 reports
9
SEROTONIN SYNDROME
252 reports
10
ANAPHYLACTIC SHOCK
249 reports