SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menlo Park, CA 94025, NDC 10599-003-01.

FDA recall notice · announced January 25, 2023 · Intersect Ent

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Reason for recall

Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.

Notes

Distribution: Nationwide
Lot/code information: Lot #s: 10111003, Exp 12/31/2022; 10203002, Exp 01/31/2023; 10302002, 10325001, Exp 02/28/2023; 10519001, 10526002, Exp 04/30/2023; 10602002, Exp 05/31/2023; 10819004, Exp 09/30/2023; 21092101, 21111901, Exp 10/31/2023; 21110402, Exp 12/31/2023.
Quantity: 9898 pouches
Status: Terminated
Products in this recall event:
- SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menlo Park, CA 94025, NDC 10599-003-01. (D-0167-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.