Company led drug alert – Docetaxel Injection 160mg /16ml and Docetaxel Injection 20mg / 2ml

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.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 24 June 2019

• Message type: Medicines recall/notification
• Issued: 24 June 2019

CLDA Number

CLDA (19)A/04

MDR Number

MDR 73-07/18

Company name

Pfizer UK Limited

Product description

Docetaxel Injection 160mg /16ml Docetaxel Injection 20mg / 2ml

Batch Number/ Expiry

Batch number	Strength	Expiry Date
S0150518	20mg/2mL	31-Oct-2020
S0390218	160mg/16mL	31-Oct-2020
S0120218	160mg/16mL	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 24 June 2019