Why it was recalled
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
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 numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0167-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 4, 2023
- FDA report date
- Jan 25, 2023
- Quantity
- 9898 pouches
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Intersect ENT, Inc.
Original FDA data
Every field from FDA enforcement report D-0167-2023, exactly as published.
Show all FDA fields
- City
- Menlo Park
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 91348
- Address
- 1555 Adams Dr
- 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.
- Postal code
- 94025-1439
- Report date
- Jan 25, 2023
- Product type
- Drugs
- Recall number
- D-0167-2023
- Classification
- Class III
- Recalling firm
- Intersect ENT, Inc.
- Product quantity
- 9898 pouches
- Termination date
- Aug 21, 2024
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 4, 2023
- Initial firm notification
- Letter
- Center classification date
- Jan 19, 2023