Dear Doctor Letter (Rote-Hand-Brief) on Oncaspar® solution for injection (pegasparaginase): Possible quality deficiency
2013.11.19
Active substance: pegasparaginase
The company Sigma-Tau Arzneimittel GmbH is circulating information that individual containers from different batches have exhibited fine cracks that can lead to leakage (assumed incidence: one in every 5,000 injection vials). Due to these fine cracks there is the possibility of microbial contamination of the solution which can pose a risk of infection to patients.
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