Class 2 Medicines Recall: Sanofi Fasturtec 7.5 mg, 1.5 mg/ml powder and solvent for concentrate for solution for infusion, EL (20)A/40

Sanofi is recalling batch number A9306 of the above product as a precautionary measure due to an out of specification result detected for Rasburicase enzyme activity according to a specific method and specifications for US market, at 12 months stability time point.

MDR Number

MDR 091-08/20

Company Name

Sanofi

Product description

Fasturtec 7.5mg (1.5mg/ml) powder and solvent for concentrate for solution for infusion

Marketing authorisation number(s): EU/1/00/170/002

Batch Number Expiry Date Pack Size First Distributed
A9306 02 / 2022 7.5mg vial 14/11/2019

Generic Name: rasburicase

Advice for healthcare professionals

Stop supplying the above batch immediately. Quarantine all remaining batch stock and return it to your supplier using your supplier’s approved process.

Further information

For medical information enquiries please contact uk-medicalinformation@sanofi.com, 0800 035 25 25. For stock control enquiries please contact GB-CustomerServices@sanofi.com, 0800 854 430.

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

NHS regional teams are asked to forward this alert to community pharmacists and dispensing general practitioners for information.

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EL (20)A/40

Updates to this page

Published 24 August 2020