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VISCO-3 sodium hyaluronate

SEIKAGAKU CORPORATION · Model 00-1111-001-03 · UDI-DI 04987541301314

MOZ Prescription

510(k) clearances

8,423

Adverse events (310 deaths)

Recalls

Facilities

Description

VISCO-3 (P980044/S027) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. VISCO-3 is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from chicken combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. VISCO-3 is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).

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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Data 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.