The Medicines and Healthcare products Regulatory Agency (MHRA) today issued a class 2 medicines recall for three batches of Losartan tablets made by Accord Healthcare Limited, citing contamination with the nitrosamine N-nitroso-N-methylamino butyric acid (NMBA).
The recall is part of the continued investigation into potential nitrosamine contamination of sartan containing drugs that mainly used for the treatment of high blood pressure and heart failure.
Healthcare professionals and wholesalers are directed to immediately stop supplying these batches, quarantine all remaining stock and return it to using the supplier’s approved process.
MHRA suggested patients to consult with their doctor or pharmacist if they have any concerns regarding the medicine. Healthcare professionals should advise patients to continue taking their medication as the health risk of discontinuing it is higher than the potential risk presented by the contaminant.
The investigation into possible contamination of sartan medicines began in 2018 after NDMA presence was identified in Valsartan manufactured in a Chinese facility.
“Our priority as regulator is to make sure the medicines you and your family take are effective and acceptably safe,” Bernadette Sinclair-Jenkins, MHRA’s Manager, Regulatory Assessment Unit of Inspection, Enforcement and Standards Division, said.
“There is no evidence at present that medicines containing NDMA, NDEA or NMBA have caused any harm to patients and this recall is a precautionary measure.”
Last year, MHRA recalled batches of Valsartan containing tablets to pharmacy and wholesaler level as a precautionary measure due to possible contamination with N-nitrosodiethylamine (NDEA) and NDMA.
The MHRA also recalled batches of Irbesartan containing tablets in January and February this year, after possible NDEA contamination was found in the drug.