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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