Central Alerting System: Class 2 Drug Alert, Action Within 48 Hours, Sanofi, Fasturtec 7.5mg/5ml Powder And Solvent For Concentrate For Solution For Infusion
An Out Of Specification result has been detected for Rasburicase enzyme activity for batch number A9306. As a precautionary measure, Sanofi is requesting that all affected batches are quarantined and returned to the supplier.
Source:
Medicines and Healthcare products Regulatory Agency