Medicine recall 24 June 2019

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

Yes – this has been recalled
The problem
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.
What to do
Check the batch number on your pack against the list below. Do not stop taking a prescribed medicine without talking to your pharmacist, GP or prescriber first – they can check your supply and swap it if needed.
Source: Medicines and Healthcare products Regulatory Agency (MHRA) Official notice ↗

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

Updated 24 June 2019. This page summarises an official notice. Details can change – always follow the official notice.

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