Specials manufacturer Syri Ltd has been fined £51,000 and ordered to pay costs of £104,898 by Aylesbury Crown Court after the company was convicted of supplying a medicinal product which was not of the nature or quality specified in a prescription. The investigation was prompted by a child suffering multiple seizures and their admission to hospital.
The child was prescribed magnesium glycerophosphate to help prevent seizures. However, the medicine made by the company contained just 12 per cent of the strength specified in the prescription, which resulted in it failing to work effectively.
The Medicines and Healthcare products Regulatory Agency (MHRA) was alerted to the issue following a report from Milton Keynes University Hospital. MHRA inspectors visited the site and found the methods used to manufacture the medicine and the checks in place to ensure appropriate standards were not met at the time the medicine was supplied.
The company has since improved its quality assurance procedures to prevent a recurrence. However, in a statement, Laura Walters, Special Crown Prosecutor of the Crown Prosecution Service said: “This was not an isolated mistake although our prosecution was only concerned with this one serious incident.”
Anyone who suspects that they, or a member of their family, may have experienced a side effect from a medicine can report it to the MHRA’s Yellow Card scheme, which collects and monitors information on suspected safety concerns involving healthcare products.