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19 July 2021 by Jacquie Lee

Class 4 Medicines Defect Information, Amoxicillin 500 mg/ 5 ml Powder for oral suspension, (PL 25298/0248), EL (21)A/18

  • Wales
  • England
  • Scotland
  • Northern Ireland

Brown & Burk UK Limited have noticed an error regarding specific batches of Amoxicillin 500 mg/ 5 ml Powder for oral suspension. The product information incorrectly states the quantity of the excipient sodium benzoate.

MDR Number MDR 232-06/21

Company name Brown & Burk UK Limited

Product description Amoxicillin 500 mg/ 5 ml Powder for oral suspension PL 25298/0248

Details of the affected batch:

Batch number

Expiry date

Pack size

First distributed

ASDBV0001

Nov. 2022

100ml (When reconstituted)

14 June 2021

ASDBV0002

Nov. 2022

100ml (When reconstituted)

not yet distributed

ASDBV0003

Nov. 2022

100ml (When reconstituted)

not yet distributed

Brief description of problem

Brown & Burk UK Limited would like to notify you of an error regarding specific batches of Amoxicillin 500 mg/ 5 ml Powder for oral suspension, sold and distributed in the UK. The product information incorrectly states the quantity of the excipient sodium benzoate. The actual quantity of sodium benzoate is 3.75mg/5ml. On the PIL it is incorrectly reported as 7.5mg/5ml and in the SmPC it is 15mg/5ml (1.5mg/ml).

Advice to Healthcare Professionals

There is no risk to product quality as a result of this issue, therefore the associated batches are not being recalled at this time. The batches not yet distributed have been included in this alert to inform HCPs accordingly. These batches were subject to a batch specific variation, assessed by the MHRA and it was considered that the risk associated with the incorrect information was low and therefore no market action considered.

The product information is in the process of being revised to reflect the correct quantity of sodium benzoate and new batches will be only be distributed with the correct information.

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.

Company contacts for further information

For more information, medical information queries please contact: Email: pv@bbukltd.com

For stock enquiries please contact:  Email: customercare@bbukltd.com

Tel: 0203 384 7188

To access the full recall: Class 4 Medicines Defect Information, Amoxicillin 500 mg/ 5 ml Powder for oral suspension, (PL 25298/0248), EL (21)A/18

 

Drug alert class 4

Drug alert class 4

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