Class 4

Class 4 Medicines Defect Information: Diuril Oral Solution (unlicensed medicine), Mawdsley-Brooks & Company Limited, EL (21)A/32

Error with the patient information leaflet (PIL) that has been provided with Diuril Oral Solution, supplied by Mawdsley-Brooks & Company Limited.

MDR Number: MDR 241-11/21

Company name: Mawdsley-Brooks & Company Limited

Product description: Diuril Oral Solution (unlicensed medicine)

Details of the affected batches:

Batch Number

Expiry Date

Pack Size

First Distributed

0483640

11/2023

237ml

18/10/2021

0342573

07/2023

237ml

08/07/2021

0342571

07/2023

237ml

10/08/2021

0332499

07/2023

237ml

11/03/2021

0332497

07/2023

237ml

09/11/2020

0322467

07/2023

237ml

28/04/2021

0322465

07/2023

237ml

27/05/2021

Brief description of problem:

Mawdsley-Brooks & Company Limited would like to notify you of an error with the patient information leaflet (PIL) that has been provided with the below batches of products. The PIL provided was a newer version of the PIL which did not include the correct ingredient information. The discrepancy surrounds the alcohol content within the product, the details are as below:

The bottle, carton and PIL inside the pack correctly states the alcohol content as 0.5% whilst the PIL provided by Mawdsley-Brooks & Company Limited states 0.4%.

Active Pharmaceutical Ingredient: Chlorothiazide

Advice to Healthcare Professionals:

There is no risk to product quality or patient safety as a result of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the product and use the manufacturers PIL inserted in the pack.

Company contacts for further information:

For more information, medical information queries or replacement PIL enquiries, please contact: Charlotte Ray - charlotte.ray@mawdsleys.co.uk.

For stock control queries, please contact: Unlicensed@mawdsleys.co.uk

To access the full recall: Class 4 Medicines Defect Information: Diuril Oral Solution (unlicensed medicine), Mawdsley-Brooks & Company Limited, EL (21)A/32