Intersect ENT recalls SINUVA (mometasone furoate) sinus implants with failed dissolution specification. Product did not meet 24-hour drug release rate at 9 months stability. Rx-only medication for sinus issues.
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
Intersect ENT has recalled SINUVA sinus implants that failed to release medication properly over time. This could lead to incorrect dosing if used as intended. The recall applies to specific lot numbers and expiration dates.
The medication did not release the drug at the correct rate over time. This could mean incorrect dosing if the implant fails to dissolve properly. However, the product is prescription-only and the risk is not immediate.
People with prescriptions for SINUVA sinus implants from Intersect ENT. Those with the specific lot numbers and expiration dates listed are most at risk.
Check your prescription label for the SINUVA product name, lot numbers (10111003 through 21110402), and expiration dates (up to 12/31/2023). The product is only available by prescription.
Review your prescription label for the SINUVA product name, lot numbers, and expiration dates to confirm if it is recalled.
The product is prescription-only and has been recalled due to a failure in drug release specification, but it is not unsafe for immediate use. The risk is low and specific to the recalled lots.
Check your prescription label for the specific lot numbers and expiration dates. If it matches the recalled list, contact Intersect ENT for guidance.
Look for the lot numbers (10111003 through 21110402) and expiration dates (up to 12/31/2023) on your prescription label.
We’ve drafted a message you can send Intersect ENT to request your refund or repair — edit it as you like.
Subject: Recall D-0167-2023 — Intersect ENT Intersect ENT Hello, I own a Intersect ENT that is covered by recall D-0167-2023 from Intersect ENT. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
