Medicine recall 12 November 2018

Mitomycin-C Kyowa: Company-led Drug Alert

Yes – this has been recalled
The problem
The above batch is being recalled because an out of specification result for sub visible particles was recorded at the 39 month time point
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

CLDA number

CLDA (18)A/09

MDR number

MDR 06-11/18

Company name

Kyowa Kirin

Product description

Mitomycin-C Kyowa 10mg Powder for Solution for Injection PL 16508/0043

Batch number/expiry

Batch Number Expiry Date
6058517 June 2019

Brief description of the problem

The above batch is being recalled because an out of specification result for sub visible particles was recorded at the 39 month time point.

Company contact for stock enquiries:

Martin Smith

Tel: 01896 664030

Email: Martin.Smith@kyowakirin.com

Company contact for medical information enquiries:

Gary Speake

Tel: 01896 664029

Email: Medicalaffairs@kyowakirin.com or Gary.speake@kyowakirin.com

Updated 12 November 2018. This page summarises an official notice. Details can change – always follow the official notice.

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