January 2023 FDA Recall Sinuva by Intersect Ent, Inc. (D-0167-2023 - Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.)

This Class III drug recall was voluntarily initiated by Intersect Ent, Inc. on January 4, 2023 for the product Sinuva. The FDA reported the reason for recall as failed dissolution specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0167-2023

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.
Initiated
01-04-2023
Reported
01-25-2023
Quantity
9898 pouches

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91348
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Intersect ENT, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-21-2024
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration 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.

Affected Packages Involved in this Recall

10599-003-01 Sinuva