Treatment for type 2 diabetes recalled by MHRA as precautionary measure
Published on 31 August 2021
Batch of metformin recalled from distribution after alert raised.
A recall notice has been issued for a batch of metformin after an ingredient was identified as a risk factor in developing certain forms of cancer.
A recall notice for one batch of Metformin Hydrochloride 500mg/5ml Oral Solution (PL 00427/0139) has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA) as a precautionary measure after it was found to contain a nitrosamine impurity above accepted levels.
The impurity, nitrosodimethylamine (NDMA), has been identified as a risk factor in the development of certain cancers.
The notice from the MHRA stated that at the very low levels that have been detected, nitrosamines only have a potentially harmful effect if consumed over a long period of time and to date there is no evidence that this impurity has caused any harm to patients.
The Class 2 recall of batch number 0LL0018 with an expiry date of November 2021 in a pack size of 150ml is a precautionary measure to prevent further exposure and is for pharmacies and wholesalers. This is not a patient-level recall.
The marketing authorisation holder has placed all remaining stock on hold while they investigate this issue further. No other batches have been found to be affected.
The MHRA has issued the following advice for patients: “Patients are advised to continue to take their medication as directed by their HCP and should not stop any treatments without consulting their healthcare team. The risks of suddenly stopping medication for type 2 diabetes is higher than the potential risk presented by the impurity. Individuals who are concerned should talk to their pharmacist or GP.
“The MHRA continues to work with the Department of Health and Social Care to ensure that an adequate supply of these products remains available for patients.”
If you have any queries, please email MHRACustomerServices@mhra.gov.uk
Metformin is a medicine used to treat type 2 diabetes and to help prevent the condition for those at high risk of developing it.
People with type 2 diabetes do not create enough insulin and can experience hyperglycaemia (high blood sugar levels). Metformin works by lowering blood sugar levels and the way the body handles insulin.
Metformin is usually prescribed for people with type 2 diabetes when diet and exercise alone have not been effective at controlling blood sugar levels.
The treatment is available on prescription in the form of tablets and as a liquid that people can drink.
Metformin is also used at a treatment for women with polycystic ovary syndrome (PCOS) and can lower insulin and blood sugar levels, in addition to stimulating ovulation.