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.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 22 October 2019

• Message type: Medicines recall/notification
• Issued: 22 October 2019

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: S0130118
  • Expiry date: 31-Jul-2020
  • Strength: 80mg/8mL
• Batch number: S0140518
  • Expiry date: 31-Jul-2020
  • Strength: 80mg/8mL

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