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

Specific batch distributed by Sandoz Ltd is being recalled due to particulate matter found in samples.

From:
Medicines and Healthcare products Regulatory Agency
Published
17 December 2015
Last updated
18 December 2015 — See all updates
Message type:
Medicines recall/notification
Medical specialty:
Pharmacy
Issued:
17 December 2015

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

Published 17 December 2015
Last updated 18 December 2015 + show all updates

  1. Correction to drug alert for Fludarabine 25mg/ml, 1 x 2ml - EBEWE Pharma Ges.m.g.h (CLDA (15) A/13) - it's 1 x 2ml not 1 x 50ml.

  2. First published.