The United Kingdom: Unlicensed medicine Phenytoin 90mg/5ml Oral Suspension - company led recall (English Only)
 
Medicines and Healthcare products Regulatory Agency (MHRA) announces that Rosemont Pharmaceuticals Limited is issuing a company-led drug alert for an unlicensed medicine Phenytoin 90mg/5ml Oral Suspension. The four affected batches (expiry date) are: 6KL0035 (Oct 2018), 7CL0043 (Apr 2019), 7KL0045 (Oct 2019) and 8BL0033 (Jan 2020). 

The above batches are being recalled to pharmacy level as a precaution due to the generation of data which indicates that the product becomes difficult to resuspend over shelf life. The product is also being discontinued with immediate effect. The recall is to pharmacy level so there is no requirement to recall stock from patients. Healthcare professionals should, however, contact affected patients to make them aware of the discontinuation of the product and to advise them to contact their doctor as soon as possible to seek alternative medication. Patients should not stop taking their medicine and should contact their doctor as soon as possible to discuss alternative medication. 

Please refer to the following website in MHRA for details: http://www.gov.uk/drug-device-alerts/unlicensed-medicine-phenytoin-90mg-5ml-oral-suspension-company-led-recall 

In Hong Kong, the above product is not a registered pharmaceutical product. 

Ends/Thursday, May 17, 2018 
Issued at HKT 15:00 

 轉載自衛生署藥物辦公室網頁http://www.drugoffice.gov.hk/