Voluntary Market Withdrawal of Octagam 10% Announced
Octapharma has initiated a voluntary market withdrawal of Octagam 10% (immune globulin intravenous [human]) liquid preparation with the following lot numbers: K724B8541 (Exp 6/14/19) & K725A8541 (Exp 6/23/19).
The Company has decided in conjunction with the FDA to suspend further administration of Octagam 10% from these specific production lots. There have been no reports of serious injury to date. Distributors in possession of the affected lots are requested to quarantine these products immediately and arrange for return.
Octapharma 10%, an immune globulin, is indicated to treat chronic immune thrombocytopenic purpura (ITP). It is available as 2g/20mL, 5g/50mL, 10g/100mL, and 20g/200mL strength liquid for IV infusion in single-use bottles.
For more information call (888) 429-4535 or visit FDA.gov.