Sanofi-Aventis products voluntarily recalled – FDA
MANILA, Philippines - The Food and Drug Administration (FDA) yesterday advised the public about the voluntary recall by Sanofi-Aventis Philippines of certain batches of a biological product indicated for immunosuppression.
FDA director general Kenneth Hartigan-Go said specific batches of Rabbit Anti-Human Thymocyte Immunoglobulin (Thymoglobuline) Powder for IV infusion have been recalled “due to out of specification findings on the product stability prior to the expiration date.â€
These batches are C1272H08, C1282H20 and C1282H31. The listed manufacturing name and address are Genzyme Polyclonals S.A.S 1541 Avenue Marcel Merieux Batiments C4 ET C5, 69280 Marcy L’etoile, France.
Go said the product is “indicated for immunosuppression in transplantation or prophylaxis and treatment of graft rejection.†It is also used for the treatment of severe aplastic anemia.
“The batches of Thymoglobuline showed a trend of increasing molecular size, approaching the upper limit of 5.0 percent for polymers, with observed aggregation and fragmentation,†the FDA said.
The “unusual trend was attributed to technical issues in preventive maintenance of the stoppers, which increased the residual moisture inside the product and cause aggregation of lyophilized powder,†it added.
Go advised consumers to report to the FDA any suspected adverse reaction experienced from the product.
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