Class 4 Drug Alert, certain Baxter Potassium Chloride containing intravenous infusions

Baxter Healthcare Limited has informed us that a quality defect has been identified with the above product where the front panel of a small number of infusion bags was found to be missing the red text.

Company name

Baxter Healthcare Limited

Product description

Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Solution for Infusion – BP, 1000ml, Product code FKE1764 (PL 00116/0336)

Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v Solution for Infusion, 1000ml, Product Code FKE1984 (PL 00116/0337)

Potassium Chloride 0.15% w/v and Glucose 10% w/v Solution for Infusion, 500ml Product Code FE3737 (PL 00116/0656)

Brief description of the problem

Baxter Healthcare Limited has informed us that a quality defect has been identified with the above products where the front panel of a small number of infusion bags was found to be missing the red text.

The red text highlights the presence of potassium chloride in the products formulation which is a risk-mitigating factor in the prevention of a potential mix-up with other solutions for infusion. See Appendix 2 in the pdf attachment for correct label texts.

Advice for healthcare professionals

  • Please check your complete inventory of the above products and inspect the print on each bag to ensure the presence of the red print. This includes stock within your pharmacy, on wards and at any other relevant location within your hospital
  • Please consider the possibility that the absence of red text may have resulted in units being stored in the incorrect location so please ensure that all locations where infusion bags are stored are checked.
  • If units have been supplied to any other facilities or departments within your institution, please forward a copy of this letter to them.
  • If you have any home patients who use these products, please notify them.

Further information

Should any units be identified without the red print, please place those units in quarantine and notify Baxter by email: uk_shs_qa_complaints@baxter.com or by telephone: 01604 704 603 (Baxter reference number: FA-2019-026).

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

Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU

Telephone 020 3080 6574

Appendix 1: Tables of affected batches

Potassium Chloride 0.15% w/v and Glucose 10% w/v Solution for Infusion, 500ml, PL 0116/0656, Product Code FE3737. Distributed from August 2017

Batch Manufacture Date Expiry Date
17H11T2G 11/08/2017 Jul-19
17L01T2F 01/12/2017 Nov-19
18C26T2C 26/03/2018 Feb-20
18C26T2CA 26/03/2018 Feb-20
18C26T2CB 26/03/2018 Feb-20
18I24T2H 24/09/2018 Aug-20
18J08T2A 08/10/2018 Sep-20
19D10T2C 10/04/2019 Mar-21

Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Solution for Infusion – BP, 1000ml, PL 00116/0336, Product Code FKE1764. Distributed from August 2016

Batch Manufacture Date Expiry Date
16G13T2C 13/07/2016 Jun-19
16H03T1F 03/08/2016 Jul-19
16J10T1B 10/10/2016 Sep-19
16L12T1D 12/12/2016 Nov-19
17A26T2D 26/01/2017 Dec-19
17D25T1G 25/04/2017 Mar-20
17E31T1B 31/05/2017 Apr-20
17H22T2G 22/08/2017 Jul-20
17I28T2C 28/09/2017 Aug-20
17L02T1B 02/12/2017 Nov-20
17L22T2G 22/12/2017 Nov-20
18B02T1B 02/02/2018 Jan-21
18B02T1B 02/02/2018 Jan-21
18B03T1H 03/02/2018 Jan-21
18D06T1G 06/04/2018 Mar-21
18E15T2E 15/05/2018 Apr-21
18E15T2EA 15/05/2018 Apr-21
18G05T1C 05/07/2018 Jun-21
18H21T2D 21/08/2018 Jul-21
18I18T1E 18/09/2018 Aug-21
18J03T1F 03/10/2018 Sep-21
18K05T2C 05/11/2018 Oct-21
18K21T2H 21/11/2018 Oct-21
18L20T1D 20/12/2018 Nov-21
19B03T1E 03/02/2019 Jan-22
19D05T2A 05/04/2019 Mar-22

Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v Solution for Infusion, 1000ml, PL 00116/0337, Product Code FKE1984. Distributed from September 2016

Batch Manufacture Date Expiry Date    
16H02T1B 02/08/2016 Jul-19    
16I15T1B 15/09/2016 Aug-19    
16J18T1A 18/10/2016 Sep-19    
16K21T1D 21/11/2016 Oct-19    
16L19T2G 19/12/2016 Nov-19    
17B03T1D 03/02/2017 Jan-20    
17B03T1DA 03/02/2017 Jan-20    
17C15T2E 15/03/2017 Feb-20    
17D18T1B 18/04/2017 Mar-20    
17D18T1BA 18/04/2017 Mar-20    
17E09T1B 09/05/2017 Apr-20    
17F06T1F 06/06/2017 May-20    
17G11T2A 11/07/2017 Jun-20    
17I19T2A 19/09/2017 Aug-20    
17K08T1H 08/11/2017 Oct-20    
17L13T2B 13/12/2017 Nov-20    
18A05T2B 05/01/2018 Dec-20    
18A31T1B 31/01/2018 Dec-20    
18B14T2C 14/02/2018 Jan-21    
18C09T1G 09/03/2018 Feb-21    
18D19T2B 19/04/2018 Mar-21    
18D30T1F 30/04/2018 Mar-21    
18E21T2C 21/05/2018 Apr-21    
18F12T1G 12/06/2018 May-21    
18F12T1GA 12/06/2018 May-21    
18F19T1F 19/06/2018 May-21    
18G19T1F 19/07/2018 Jun-21    
18H29T2C 29/08/2018 Jul-21    
18I19T1C 19/09/2018 Aug-21    
18J17T2H 18/10/2018 Sep-21    
18J24T2H 24/10/2018 Sep-21    
18K20T2H 20/11/2018 Oct-21    
18K25T2G 25/11/2018 Oct-21    
19A07T1C 07/01/2019 Dec-21    
19B04T2E 04/02/2019 Jan-22    
19B18T2C 18/02/2019 Jan-22    
19C19T2A 19/03/2019 Feb-22    
19D07T2H 07/04/2019 Mar-22    

Download the document

Note: see document below for more details including images of affected batches.

Drug alert: Baxter Potassium Chloride (MDR 62-05/19)

Published 3 June 2019