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Sanofi Genzyme recalls Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous high molecular weight
Recalled February 21, 2018 · FDA recall Z-0607-2018 · Sanofi Genzyme
Hazard
Contamination with Methylbacterium thiocyanatum · FDA Class II
Units
12,380 units
Sold at
US Nationwide distribution(36 states)
Description
Contamination with Methylbacterium thiocyanatum
Product
Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous high molecular weight fluid containing hylan A and hylan B polymers produced from chicken combs. Synvisc-One is administered as a single intra-articular injection. Synvisc-One is indicated for the 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.
Manufacturer(s)
Sanofi Genzyme
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →