On December 11, 2017, Sanofi Genzyme distributed recall notices and reply cards to their customers via courier service, FDA said. Customers were advised to inspect their inventory, immediately discontinue use and return all affected products. On December 19, 2017, the company distributed a 2nd notice informing customers that the contamination was from a bacterial organism known as Methylbacterium thiocyanatum. The manufacturer issued a 3rd notice on December 22, 2017, which included antibiotic sensitivity analysis guidance for the isolated organism. The potentially contaminated Synvisc-One injections belonged to lot 7RSL021 and were initially distributed to 36 states on Oct. 25, 2017, according to the FDA.
What is Synvisc?
The Synvisc-One injection is used to treat pain in osteoarthritis (OA) of the knee in patients who have failed to respond to non-pharmacologic therapy and simple analgesics, e.g., acetaminophen, according to the FDA. The medicine is administered as a single intra-articular injection. Synvisc was approved by the FDA in February 2009, and is manufactured by Sanofi Genzyme.
Synvisc-One Side Effects
- Fluid buildup around knee
- Trouble walking
- Outpatient procedures
- Emergency Room Visit
- And more
Not the First Time Genzyme Accused of Violations
In 2001, FDA warned Genzyme about problems at its manufacturing plant in Ridgefield, New Jersey. FDA asked the company to fix the problems, including obtaining the proper clearance for certain medical products and responding to customer complaints.
Sanofi Genzyme asked customers to “Immediately discontinue use of the Synvisc-One lot number 7RSL021” and that “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.”
Do I Have a Synvisc-One Lawsuit?
The Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Synvisc-One lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Again, if you or a loved one has been harmed by the side effects of Synvisc-One, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.