Medicine recalls
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| The United Kingdom: Class 2 Medicines Recall: Aventis Pharma Limited (t/a Sanofi), Stemetil 5mg/5ml Syrup |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Aventis Pharma Limited (t/a Sanofi) is recalling all batches of Stemetil 5mg/5ml Syrup (prochlorperazine mesilate) (batch number: 0032, 0033, 0034, 0035) as a precautionary measure due to the identification of N-nitrosomethylphenylamine (NMPA) above the acceptable limit.
Nitrosamines may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time. Healthcare professionals should advise patients undergoing treatment not to discontinue Stemetil Syrup without consulting with their prescriber. If this medicine was abruptly withdrawn, there is a possibility of the return of symptoms for which Stemetil Syrup was prescribed, and more rarely, withdrawal reactions such as nausea, vomiting, insomnia and movement disorders.
Based on the available data, there is no immediate risk to patients who have been taking this medication. Patients should be advised to discuss any questions or concerns with their prescribing healthcare professional.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-aventis-pharma-limited-t-slash-a-sanofi-stemetil-5mg-slash-5ml-syrup-el-22-a-slash-41
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Oct 7, 2022
Issued at HKT 13:00
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