Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: Diuril Oral Solution, Mawdsley-Brooks & Company Limited |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Mawdsley-Brooks & Company Limited has identified an error with the patient information leaflet (PIL) that has been provided with Diuril Oral Solution (chlorothiazide) (batch number: 0483640, 0342573, 0342571, 0332499, 0332497, 0322467, 0322465). The PIL provided was a newer version of the PIL which did not include the correct ingredient information. 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%.
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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-diuril-oral-solution-unlicensed-medicine-mawdsley-brooks-and-company-limited-el-21-a-slash-32
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Nov 30, 2021
Issued at HKT 14:00
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