Sanofi has informed us of an Out Of Specification (OOS) result which was detected for Rasburicase enzyme activity according to a specific method and specifications for the US market, at 12 months stability time point. Sanofi is recalling Fasturtec 7.5mg (Rasburicase) Solution for IV infusion - 7.5mg/5ml (Injectable powder in vial packaged with 5ml solvent in ampoule) batch number A9306, as a precautionary measure.
Advice for healthcare professionals:
- Stop supplying the above batch immediately. Quarantine all remaining stock and return these to your supplier using your supplier's approved process.
Full details of the drug alert are included in the attached PDF file. Please forward to listed recipients. This information is also published on the MHRA website https://www.gov.uk/drug-device-alerts.