Sanofi has initiated a U.S. recall of a lot of its injected gel for treating arthritis in knees which has tested positive for microbial contamination and been linked to some adverse events.
Sanofi spokeswoman Ashleigh Koss confirmed today 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.
Genzyme is based in Cambridge, Massachusetts. The recall was first reported in the Boston Globe.
Sanofi put a hold on the lot last week after getting a surge of adverse event reports. Koss said the adverse events have been consistent with the product labeling and there have been no deaths.
In a letter to providers the company said, "This is a voluntary product recall due to an ongoing investigation in which subsequent investigational testing revealed the presence of microbial contamination. ....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."
Synvisc One, which was approved by the FDA in 2009, generated nearly $410 million in sales last year. The lubricant and shock-absorbing gel is injected into the knee to provide up to 6 months' worth of relief for people with arthritis of the knee.
About this time last year, the French drugmaker ran into problems at a plant in France that produced another injected arthritis med. In that case, a long list of deficiencies at the fill-finish plant in Le Trait, France, led the FDA to issue a complete response letter to Sanofi and partner Regeneron for experimental rheumatoid arthritis drug, and expected blockbuster, sarilumab. After more than 6 months of work on the plant, the FDA finally approved the drug, sold as Kevzara.