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 The PIL provided was a newer version of the PIL which did not include the correct ingredient information.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