Sanofi Genzyme recalls Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous high molecular weight fl…

Recall date

December 11, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0607-2018

FDA classification

Class II

Brand / firm

Sanofi Genzyme

Sold / distributed

US Nationwide distribution(36 states)

Why it was recalled

Contamination with Methylbacterium thiocyanatum

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.