Taxotere (Docetaxel) Concentrate for Solution for Infusion, 80mg per 4ml EU/1/95/002/004 (CLDA (16)A/02)

Sanofi are recalling the listed batches of Taxotere (Docetaxel) Concentrate due to a production fault potentially leading to an increase in the concentration of Docetaxel in the solution.

Product information

CLDA number

CLDA (16)A/02

MDR number

MDR 32-04/16

Company name

Sanofi

Product description

Taxotere (Docetaxel) Concentrate for Solution for Infusion, 80mg per 4ml EU/1/95/002/004

Batch number/expiry

Batch no Expiry date
5F219A 31 August 2018

Brief description of the problem

A software failure during filling of this batch has potentially resulted in the evaporation of Ethanol from a small number of vials and a consequent increase in the concentration of Docetaxel in the solution. The total amount of Docetaxel per vial is not impacted. The incidence rate for the 4ml presentation is estimated to be about 0.09%

Company contact for all enquiries

Sanofi Medical Information Department
Tel: 0845 3727101

Email: UK-Medicalinformation@sanofi.com

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