Fresenius Kabi and Calea Fined for Faulty Prefilled Syringes

July 15, 2015
BioPharm International Editors

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