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Sanofi voluntarily recalls arthritis drug
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Sanofi has issued a limited voluntary recall of its Synvisc-One, an injected gel for treating arthritis, due to an ongoing investigation that revealed the presence of microbial contamination.
The recall is being applied to a single lot of the drug, made up of 12,380 syringes produced by Sanofi Genzyme at a plant in Ridgefield, New Jersey, according to Ashleigh Koss, head of media relations for Sanofi. The lot, identified in a press statement as Lot 7RSL021, was distributed Oct. 25 through Nov. 7 of this year, and only in the U.S. market.
“This is a voluntary recall of one single batch, with about 12,000-plus syringes, and only in the United States,” Koss told Healio Rheumatology. “Our concerns are with the patient, so if anyone has any additional questions, they can contact us.”
According to a company press statement, the adverse effects reported in association with the recalled lot are consistent with documented adverse events on the product label. Sanofi issued the recall on Dec. 13 at the physician and wholesale/pharmacy level.
“Sanofi Genzyme is working with its distributors to ensure that all product in the specified lot is returned to the company,” the press statement said. “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.”
According to the company, health care providers should direct all medical and clinical questions to Sanofi Medical Information Services in the United States at 1-800-633-1610, option 1.
In addition, the company is directing all patient inquiries to Sanofi U.S. customer service, at 1-800-633-1610, option 7 then 4. – by Jason Laday
Disclosure: Koss reports employment with Sanofi.