A cancer patient died and four others spent time in hospital after a pharmaceutical company gave them "unlicensed" chemotherapy medicine.
The health watchdog has now launched a probe as Sciensus, which provides treatment to around 200,000 in the UK, admitted the blunder. An unlicensed version of prostate cancer medicine cabazitaxel was given to four patients, including the one who later died.
The patients have not been named, nor have any further details, including their ages and where they lived, been disclosed at this stage. The three other patients were treated in hospital in April, it has today emerged.
The Medicines and Healthcare products Regulatory Agency (MHRA) offered its "deepest sympathies" and has vowed to take "any necessary regulatory measures" to protect patients. The Care Quality Commission and the General Pharmaceutical Council are aiding MHRA in its investigation.
A spokesman for Sciensus said "an isolated incident at our medicine manufacturing unit in April has affected four patients."
"We are deeply saddened that one of the patients has since died and wish to offer our sincere condolences to the patient's family and friends," he added.
"As soon as the incident was discovered, we immediately contacted the regulators, the patients and their doctors. We are currently conducting a thorough investigation into the incident and are working with the regulators."
The pharmaceutical supplier, established in 1992, is based in Burton-upon-Trent, Staffordshire, but works with every NHS trust in the UK, of which there are more than 200. The firm has around 1,600 employees, dealing with more than 230,000 patients every year.