Class 4 Medicines Defect Information: Diuril Oral Solution (unlicensed medicine) Mawdsley-Brooks & Company Limited

Class 4 Medicines Defect Information: Diuril Oral Solution (unlicensed medicine) Mawdsley-Brooks & Company Limited

November 29, 2021

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

Drug alert number: EL (22)A/32

Date issued: 29 November 2021

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:

Diuril Oral Solution (unlicensed medicine), Mawdsley-Brooks & Company Limited

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 The PIL provided was a newer version of the PIL which did not include the correct ingredient information.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

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

 

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.

View full alert here

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



Posted in: ,


More Latest News >