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Class 2 Recall on Fasturtec® 7.5 mg. 1.5 mg/ml

Recalls and Alerts

Class 2 Recall

24 Aug 2020

Class 2 Recall on Fasturtec® 7.5 mg. 1.5 mg/ml

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 US market, at 12 months stability time point. Sanofi is recalling Fasturtec® 7.5 mg (Rasburicase) Solution for IV infusion - 7.5 mg/5 ml (Injectable powder in vial packaged with 5 ml solvent in ampoule), batch number A9306 as a precautionary measure.

 

Please visit the: MHRA website for more details on this drug alert.

 

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
3338928Fasturtec® 7.5 mg. 1.5 mg/ml powder and solvent for concentrate for solution for infusionSanofiA9306

For medical information enquiries please contact uk-medicalinformation@sanofi.com Med Info Phone :0800 035 25 25.

For stock control enquiries please contact GB-CustomerServices@sanofi.com Phone number: 0800 854 430

Recipients of this Drug Alert should bring it to the attention of relevant contacts.

 

Please note that Alliance Healthcare do not stock and we are not accepting stock returns.

If you have any questions, then please contact your local Service Centre Customer Services team.