The Medicines and Healthcare Products Regulatory Agency (MHRA) has asked pharmacies to stop supplying a particular batch of Metformin Hydrochloride 500mg/5ml oral solution following identification of an impurity: N-nitrosodimethylamine (NDMA).
NDMA, having genotoxic and carcinogenic potential, has been observed at a level above the acceptable limit in the medicine.
The medicine watchdog also advised pharmacies to “quarantine all remaining stock and return it to your supplier” of the affected batch manufactured by Rosemont Pharmaceuticals Limited.
Metformin Hydrochloride is used for treating patients with type 2 diabetes and helps in controlling blood sugar level.
“Patients should be advised not to stop any treatments without consulting their relevant healthcare professional,” the watchdog said.
Though, “very low levels” of the impurity has been detected, it can be harmful if consumed over a long period of time, MHRA said.
Dr Alison Cave MHRA chief safety officer, said: “This recall of one batch of metformin oral solution is a precautionary measure to prevent further exposure to the nitrosamine impurity. There is no evidence to date that this impurity has caused any harm to patients.”
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