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)

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

Active Pharmaceutical Ingredient: Chlorothiazide

Brief description of the 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 The PIL provided was a newer version of the PIL which did not include the correct ingredient information.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 for 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.

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

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

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

Updates to this page

Published 29 November 2021