Medicine recall 17 December 2015

Fludarabine 25mg/ml, 1 x 2ml – EBEWE Pharma Ges.m.g.h (CLDA (15) A/13)

Yes – this has been recalled
The problem
Specific batch distributed by Sandoz Ltd is being recalled due to particulate matter found in samples.
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 (15) A/13

MDR number

MDR 16- 12/15

Company name

Manufacturer:

EBEWE Pharma Ges.m.g.h

Distributor:

Sandoz Ltd

Product description

Fludarabine 25mg/ml, 1 x 2ml

PL 14510/0009

Batch number/ expiry

Batch no Expiry date
ER 4824 May 2017

Brief description of the problem

Sandoz is recalling this batch because particulate matter, believed to be intrinsic to the active pharmaceutical ingredient, was identified in samples.

Company contact for all enquiries relating to the issue

Sandoz Customer Services
Telephone: 01276 698607

Updated 17 December 2015. This page summarises an official notice. Details can change – always follow the official notice.

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