Company led drug alert – Docetaxel Injection 80mg /8ml

Pfizer UK Limited is recalling batches as routine stability testing has identified that levels of a known impurity, 10-oxo-docetaxel, may exceed the acceptable level at end of shelf-life.

CLDA Number

CLDA (19)A/05

MDR Number

MDR 73-07/18

Company name

Pfizer UK Limited

Product description

Docetaxel Injection 80mg /8ml

Batch Number/ Expiry

Batch number Strength Expiry Date
S0130118 80mg/8mL 31-Jul-2020
S0140518 80mg/8mL 31-Oct-2020

Brief Description of Problem

Pfizer UK Limited is recalling the above batches. This is because routine stability testing has identified that levels of a known impurity, 10-oxo-docetaxel, may exceed the acceptable level at end of shelf-life.

Company Contact for medical information enquiries

Pfizer Medical Information, Tel 01304 616161

Published 22 October 2019