British police have charged pharmaceutical company ITH Pharma as part of an investigation into the deaths and illnesses of babies at several hospitals.
The firm is accused of seven counts of supplying a medicinal product which was not of the nature or quality specified in the prescription.
It is also charged wity failing to take all reasonably practicable steps to ensure that patients were not infected by contaminants.
ITH Pharma, based in north London, is due to appear at London's Westminster Magistrates' Court on 17 December.
An investigation was launched after three babies died and another 20 needed treatment when they contracted septicaemia in 2014.
The charges announced by the Metropolitan Police are linked to seven babies, including three who died, who were given the fluid as nutrition because they were unable to feed on their own between May 27 and June 2 2014.
The infants who died were treated at St Thomas' Hospital in London and Rosie Maternity Hospital in Cambridge.
One baby, Yousef Al-Kharboush, died at nine days old on 1 June 2014 after receiving the contaminated feed at St Thomas' Hospital.
He and his twin brother Abdulilah were born by emergency Caesarean section at the hospital at 32 weeks gestation in May 2014.
While in intensive care they were both fed intravenously, and while Abdulilah was not affected, Yousef contracted lethal blood poisoning from the feed which was contaminated with the bacteria bacillus cereus.
ITH Pharma said in a statement: "As founders of ITH we have every sympathy for all the families affected, regardless of the cause.
"However, we are disappointed by the decision to charge the company and will vigorously defend this case. It would not be appropriate to comment further at this stage.
"Since 2008, ITH has manufactured more than 1.4 million components of total parenteral nutrition and is the sole commercial supplier of reactive feeding solutions to the NHS.
"This product has helped thousands of extremely vulnerable infants survive premature and complex births.
"ITH imposes rigorous environmental monitoring on its manufacturing process.
"The company has always had a strong relationship with the MHRA (Medicines and Healthcare products Regulatory Agency) and continues to receive exemplary ratings for quality and safety."
Additional Reporting PA
