Dec 19, 2017
On December 11, 2017, Sanofi Genzyme initiated a voluntary product recall for a single lot of Synvisc-One® (hylan G-F 20) lot 7RSL021 due to an ongoing investigation which revealed the presence of microbial contamination. The microbe is a common airborne organism and is a rare cause of human infections in both immunocompromised and immunocompetent patients.
Use of this voluntarily recalled lot may result in a risk of infection. This lot was distributed October 25, 2017 through November 7, 2017 only in the US market. The most frequently reported adverse events in association with this lot are consistent with documented adverse events in the product label. This voluntary recall is being conducted with the knowledge of the US Food and Drug Administration.
No other Synvisc-One or Synvisc lots are impacted by this voluntary recall. The voluntary recall is at the physician and wholesale/pharmacy level and is isolated to one product lot.
Sanofi Genzyme is working with its distributors to ensure that all product in the specified lot is returned to the company. Sanofi Genzyme is committed to patient safety and to maintaining the highest product quality standards and we do not anticipate supply issues for Synvisc-One as a result of this voluntary product recall.
For More Information:
Health Care Providers should direct all medical and clinical questions to Sanofi Medical Information Services in the U.S. at 1-800-633-1610, option 1.
Patient inquiries regarding this voluntary recall should be directed to Sanofi U.S. Customer Service at 1-800-633-1610 option 7 then 4.
Patients who have experienced an adverse event or for Health Care Providers reporting an adverse event, all calls should be directed to Sanofi Adverse Event Reporting in the U.S. at 1-800-633-1610, option 2.
General Questions about the voluntary recall should be directed to Sanofi U.S. Customer Service at 1-800-633-1610 option 7 then 4.
For product return information related to the voluntary recalled Synvisc-One lot 7RSL021, please contact FedEx Supply Chain Solutions (GENCO) at 1-855-838-5782.