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 The PIL provided was a newer version of the PIL which did not include the correct ingredient information.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