Fresenius Kabi and Calea Fined for Faulty Prefilled Syringes
Two companies have been fined a total of GBP550,000 for faulty insulin syringes, which contained no drug and caused the death of a diabetic patient.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) reported that two companies have been sentenced for supplying faulty prefilled syringes that caused the death of a diabetic patient.
Neil Judge, from Barnsley, died at the Northern General Hospital in Sheffield in November 2010 after receiving insulin treatment from syringes that contained no insulin. The patient suffered multi-organ failure, triggered by a serious episode of diabetic ketoacidosis as a result of insulin deprivation for more than 13 hours.
The faulty syringes were supplied to Sheffield Teaching Hospitals NHS Foundation Trust by Fresenius Kabi Ltd as a licenced wholesaler for Calea UK Ltd, which manufactured the product.
Fresenius Kabi has been fined £500 000 (€695 000; $775 000) plus £5900 in costs and Calea £50 000 with £5900 costs at Sheffield Crown Court today on July 9, following prosecution by the MHRA.
Source: MHRA
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.
Pfizer Obtains Exclusive Rights to 3SBio’s Bispecific Antibody Targeting PD-1 and VEGF
July 25th 2025The licensing agreement between the two companies gives Pfizer the rights to develop, manufacture, and commercialize 3SBio’s bispecific antibody, SSGJ-707, which is in clinical trials for the treatment of a variety of cancers.
Mechanistic Hypothesis of Toxicity: Driving Decision Making in Preclinical Translation
July 16th 2025Mechanistic toxicity hypothesis is essential in guiding decision-making and predicting toxicities during the preclinical stages of drug development. The authors highlight the growing importance of integrating advanced technologies like mass spectrometry imaging into toxicology to enhance preclinical translation, foster innovation in therapeutic development, and ultimately improve drug safety and efficacy.
