Clinical news
MHRA recalls batches of stemetil
In Clinical news
Bookmark
Record learning outcomes
Sanofi is recalling batches of Stemetil 5mg/5ml Syrup after they were found to contain potentially dangerous amounts of a compound that could increase the risk of cancer.
The recall, published by the Medicines and Healthcare products Regulatory Agency, urges healthcare professionals to quarantine all remaining stock in batch numbers 0032, 0033, 0034 and 0035 and return them to their supplier amid concerns they contain more than the “acceptable limit” of N nitrosomethylphenylamine.
“Nitrosamines may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time,” the MHRA said.
The regulator also advised patients undergoing treatment not to discontinue Stemetil Syrup without consulting their prescriber and warned that symptoms such as nausea, vomiting, insomnia and movement disorders could return if they “abruptly” stopped taking the medicine.
“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,” the MHRA added.
Meanwhile, the Department of Health and Social Care has said the serious shortage protocol for Combisal 125mcg/25mcg inhalers ends at 23.59pm today after it was found that “sufficient stock” of the product was available “to meet normal demand.”