Tuesday 2 September 2014

AMSA PD Inj 50 mg/mL - Potential low risk of microbial contamination

ERFA Canada 2012 Inc. in consultation with Health Canada is informing you of a potential but very low risk of infection with AMSA PD Inj 50 mg/mL (amsacrine injection). AMSA PD is indicated for the induction of remission in acute adult leukemia refractory to conventional therapy. Due to a manufacturing issue, a very low risk of microbial contamination of the product exists which could lead to infection. A recall has not been implemented given that the risk of contamination is minimal, this drug is medically necessary for a small number of patients and because there is limited supply of product available. However, it is advised that healthcare professionals should determine if the benefit of treatment with AMSA PD Inj 50 mg/mL outweighs the potential but very low risk of infection related to use of this product. Read more here.

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