Class 3 medicine recall 23 July 2020

Accord Healthcare Limited, Irinotecan Hydrochloride Concentrate for Solution for Infusion 20mg/ml (5ml vial)

Yes – this has been recalled
The problem
Accord Healthcare Limited is recalling the above batch as a precautionary measure, due to the observation of precipitation in the solution in the same batch marketed in another country (Malta). No complaints or adverse reaction reports have been received by the company to date for…
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 ↗

Product information

PL Number

PL 20075/0443

MDR Number

MDR 074-07/20

Company name

Accord Healthcare Limited

Product description

Irinotecan Hydrochloride Concentrate for Solution for Infusion 20mg/ml (5ml vial)

  • Batch Number: X21343
  • Expiry Date: 10/2021
  • Pack Size: 1 x 5ml vial
  • First Distributed: 11/03/2019

Active Pharmaceutical Ingredient: irinotecan hydrochloride

Brief description of the problem

Accord Healthcare Limited is recalling the above batch as a precautionary measure, due to the observation of precipitation in the solution in the same batch marketed in another country (Malta). No complaints or adverse reaction reports have been received by the company to date for the UK product.

Advice for healthcare professionals

Stop supplying the above batch immediately. Quarantine all remaining stock and return these to your supplier using your supplier’s approved process.

Further Information

For more information or medical information queries, please contact:

Medinfo-BST

Tel: 01271 385257

E-mail: medinfo@accord-healthcare.com

For stock control queries, please contact:

Accord-UK Ltd Customer Services Team

Tel: 0800 373573

E-mail: customerservices@accord-healthcare.com

Fax: 01271 346106

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this notice.

NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Download the document

EL (20)A 33

Updated 23 July 2020. This page summarises an official notice. Details can change – always follow the official notice.

Website built by: www.NocturnalMedia.co.uk