Intersect ENT, Inc. FDA Recalls

2 recalls on file across drugs, devices, 0 of them Class I and 1 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, MenlClass IIIJan 4, 2023Failed Dissolution Specification; product did not meet the a	Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) spe	Class IIIDrugs	Jan 4, 2023
Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044Class IIOct 21, 2022Sinus Implant product label displays incorrect product infor	Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with	Class IIDevices	Oct 21, 2022