Friday, December 29, 2017
News this month on Sanofi's product Synvisc:
Synvisc is an injected gel used for treating arthritis in knees.
The product was tested and found to have microbial contamination. It has been linked to some adverse even that the company is voluntarily recalling 12,380 syringes of Synvisc One in conjunction with the FDA that may be contaminated. They were produced by its Genzyme unit at a plant in Ridgefield, New Jersey.
Saul Gruber in New Jersey is investigating the maker of the recalled product. Our office is investigationg. email us at mark(at)markzamora.com 866.373.1800.
The recall letter:
To Hospital / Physician Clinics, This letter is to inform you that Sanofi Genzyme is voluntarily recalling one (1) lot of Synvisc-One® (hylan G-F20) lot 7RSL021. No other Synvisc-One or SYNVISC lots are impacted by this voluntary recall.
This product was distributed between October 25, 2017 and November 07, 2017 and our records indicate that you may have received product within this time period. This is a voluntary product recall due to an ongoing investigation in which subsequent investigational testing revealed the presence of microbial contamination.
This voluntary recall is being conducted with the knowledge of the US Food and Drug Administration and we are working with your distributors to ensure that all product in lot 7RSL021 is returned. Use of this recalled lot may result in a risk of infection and therefore, we are asking that you follow the required actions below to assist us in retrieving any remaining units of this voluntarily recalled lot.
Required Actions: Patient Management Immediately discontinue use of the Synvisc-One lot number 7RSL021.
Health Care Professionals should treat their patients exposed to lot 7RSL021 in accordance with standard of care, being aware of the potential of a Gram negative infection. Product Returns Procedure
Return labels will be mailed to you as a part of the product return kit from FedEx Supply Chain Solutions (GENCO Pharmaceutical Services). If you did not receive labels in this product return kit or for information related to the recalled Synvisc-One lot 7RSL021 product returns, please contact FedEx Supply Chain Solutions (GENCO) at 1-855-838- 5782
Check your inventory and return all Synvisc-One lot number 7RSL021 as per the instructions provided below