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

News By 22nd October 2019

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