SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menl
Summary
The FDA issued a Class III for SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Onl by Intersect ENT, Inc.. Reason: Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 mon.
Details
Source
Drug Recall
External ID
D-0167-2023
Action Date
2023-01-25
Status
Terminated
Category
drug
Product Description
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.
Lot/Code Info: 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 Affected: 9898 pouches
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.
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-01-04
Company
Menlo Park, CA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 83 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Intersect ENT, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Intersect ENT, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Intersect ENT, Inc. have FDA actions?
Intersect ENT, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0167-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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