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DUROLANE
SAIMA GLOBAL FARMA S.L. · Model 1082020 · UDI-DI 08437027710001
MOZ
Prescription
0
510(k) clearances
8,410
Adverse events (307 deaths)
2
Recalls
25
Facilities
Description
DUROLANE is a clear, viscous gel that contains highly purified sodium hyaluronate. This substance acts as a lubricant and shock absorber in the knee joint. DUROLANE is used to relieve knee pain due to osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-12-11 | Sanofi Genzyme | Contamination with Methylbacterium thiocyanatum |
| 2010-04-16 | Ferring Pharmaceuticals Inc | Out of Specification results for molecular weight or viscosity through the established expiration date. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.