Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
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.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Defective Delivery System: The dip tube is clogged causing the spray not to work.
Reason Defective Container
Reason Defective Container
Reason Defective Container
Reason Defective Container
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