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

Added

1 year ago

Author

Jake

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 The PIL provided was a newer version of the PIL which did not include the correct ingredient information.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