Human Tissue Authority

The regulator for human tissue and organs

Regulatory alert 001/2017 – recall of human albumin

Issued 10 May 2017

Notice for 

•    Designated Individuals (DIs) in the Human Application (HA) sector 

Scope

This alert is being issued by the Human Tissue Authority (HTA) and includes information relevant to DIs of establishments which use human albumin during the processing of tissues or cells for human application. Please circulate this information to staff within your establishment undertaking activities which may be affected by this notice.

Issue

The HTA has been made aware of the recall of certain batches of human albumin distributed by Biotest (UK) Ltd. The recall has been prompted by low level contamination which occurred during manufacture.

The products identified in the recall notice are as follows:

Human Albumin Biotest 5% PL 04500/0011

Batch number

Expiry date

Date of first distribution

B231264_01

31/08/2017

08/05/2015

B231025_03

31/12/2017

19/03/2015

B231165_01

31/03/2018

26/06/2015

B231195_01

30/04/2018

19/10/2015

B231205_01

30/04/2018

31/05/2016

B231235_01

31/05/2018

09/08/2016

B231376_01

31/10/2019

16/03/2017

 

Human Albumin Biotest 20% PL 04500/0012

Batch number

Expiry date

Date of first distribution

B236384_02

30/06/2017

21/10/2014

B236635_01

31/10/2018

05/08/2016

B236066_01

28/02/2019

18/05/2016

B236095_05

28/02/2018

26/05/2015

B236166_03

31/03/2019

05/07/2016

B236175_01

28/02/2018

30/06/2015

B236246_02

31/05/2019

17/08/2016

B236335_01

31/05/2018

09/12/2015

B236454_01

31/07/2017

28/10/2014

B236466_01

31/10/2019

25/01/2017

B236475_01

31/08/2018

22/01/2016

B236504_03

31/08/2017

12/01/2015

B236625_02

31/10/2018

05/04/2016

B236694_01

31/10/2018

15/04/2015

B236016_05

30/09/2018

02/11/2016

The recall notice can be found here.

Action taken by the HTA

The HTA has issued this alert to ensure that all HTA-licensed establishments in the human application sector which may be using these products during the processing of tissues or cells for human application are aware of the recall notice.

Actions for establishments

Establishments using any of the products listed above should contact Biotest (UK) Ltd for further information.

Biotest (UK) Ltd Customer Services:

Tel: 0121 733 3393

Fax: 0121 733 3066

Email: mail.uk@biotest.com

Biotest (UK) Ltd company contact for medical information enquiries:

Medicines Information:

Tel: 0121 744 8444

Email: medicinesinformation.uk@biotest.com 

Establishments that have used any of these products during the processing of tissues/cells for human application should contact the HTA (tel: 020 7269 1900; email enquiries@hta.gov.uk) to discuss what action might be required. 

Audience: 
Last updated on: 10 May 2017