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
Published 20 April 2016