Medications & Supplements/Prescription Drugs

SINUVA Sinus Implants Recalled for Failed Drug Release Rate

Agency Publication Date: January 19, 2023

Summary

Intersect ENT, Inc. is recalling 9,898 pouches of SINUVA (mometasone furoate) sinus implants (1350 mcg). The recall was issued because the implants failed to meet the required drug release rate (dissolution) at the nine-month stability check. No injuries or incidents have been reported in relation to this issue.

Risk

The drug may be released from the implant more slowly than intended, which could potentially impact the effectiveness of the treatment.

What You Should Do

This recall affects SINUVA (mometasone furoate) sinus implants, 1350 mcg, sold in single-implant pouches with NDC 10599-003-01.
Check your product packaging for affected lot numbers including 10111003, 10203002, 10302002, 10325001, and others. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Intersect ENT, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: SINUVA (mometasone furoate) sinus implant

Variants: 1350 mcg, 1 implant per pouch

Lot Numbers:

10111003 (Exp 12/31/2022)

10203002 (Exp 01/31/2023)

10302002 (Exp 02/28/2023)

10325001 (Exp 02/28/2023)

10519001 (Exp 04/30/2023)

10526002 (Exp 04/30/2023)

10602002 (Exp 05/31/2023)

10819004 (Exp 09/30/2023)

21092101 (Exp 10/31/2023)

21111901 (Exp 10/31/2023)

21110402 (Exp 12/31/2023)

NDC:

10599-003-01

Rx Only; Manufactured by Intersect ENT, 1555 Adams Drive, Menlo Park, CA 94025.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91348

Status: Resolved

Manufacturer: Intersect ENT, Inc.

Sold By: Pharmacies; Hospitals; Specialty Clinics

Manufactured In: United States

Units Affected: 9898 pouches

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects SINUVA (mometasone furoate) sinus implants, 1350 mcg, sold in single-implant pouches with NDC 10599-003-01.

Check your product packaging for affected lot numbers including 10111003, 10203002, 10302002, 10325001, and others. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Intersect ENT, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: SINUVA (mometasone furoate) sinus implant

Variants: 1350 mcg, 1 implant per pouch

Lot Numbers:

10111003 (Exp 12/31/2022)

10203002 (Exp 01/31/2023)

10302002 (Exp 02/28/2023)

10325001 (Exp 02/28/2023)

10519001 (Exp 04/30/2023)

10526002 (Exp 04/30/2023)

10602002 (Exp 05/31/2023)

10819004 (Exp 09/30/2023)

21092101 (Exp 10/31/2023)

21111901 (Exp 10/31/2023)

21110402 (Exp 12/31/2023)

NDC:

10599-003-01

Rx Only; Manufactured by Intersect ENT, 1555 Adams Drive, Menlo Park, CA 94025.