Class III ยท Low risk
SINUVA (mometasone furoate)
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
National Drug Code
Is NDC 10599-0003-01 recalled?
Sinuva · 1 POUCH in 1 CARTON (10599-003-01) / 1 IMPLANT in 1 POUCH
Yes — this exact package was recalled
1 FDA recall names the code 10599-0003-01 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- mometasone furoate
- Strength
- MOMETASONE FUROATE 1350 ug/1
- Form
- Implant · Intrasinal
- Labeler
- Intersect ENT, Inc.
- Type
- Human Prescription Drug
- Product code
- 10599-0003
Recalls naming this package
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Free recall alerts
Know the day your medication is recalled
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