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Parenteral nutrition product recalled following potential contamination

Neonate

Source: Paul Brain/Dreamstime.com

Nine neonatal intensive care units in England have been affected

ITH Pharma issued a product recall on Wednesday (4 June 2014) after its parenteral nutrition product was linked to a baby’s death. A further 20 babies have suffered blood poisoning across ten neonatal intensive care units in England.

The lipid phase parenteral nutrition, which is delivered intravenously, is suspected to have been contaminated with Bacillus cereus, a bacterium found in soil.

Karen Hamling, managing director of ITH Pharma, says it would appear the potential contamination is linked to “a single raw material ingredient”.

Parenteral feeds are routinely used for babies who cannot be fed milk, says Peter Mulholland, neonatal lead at the Neonatal and Paediatric Pharmacists Group. “Very premature babies’ digestive systems have not yet fully developed and so they need intravenous parenteral feeds to survive and to help them develop.”

ITH Pharma makes each nutritional feed to order depending on the baby’s weight and clinical need.

“Preparing a parenteral feed is complex and there are risks,” says Mulholland.

The UK Medicines and Healthcare products Regulatory Agency is trying to identify the origin of the contamination and inspected ITH Pharma’s premises earlier this week (4 June 2014).

Investigations have identified an incident that might have caused the contamination, according to a joint statement by the MHRA and Public Health England.

No restriction has been placed on ITH Phama’s licence for manufacturing.

In 2011, the paediatric chief pharmacists group published a report on the provision of parenteral nutrition for neonates and children in response to some “serious incidents”, including patient deaths.

  • This article was updated on 6 June 2014 to correct the name of the Neonatal and Paediatric Pharmacists Group. It was further amended on 11 June 2014 to account for more cases of blood poisoning.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11138933

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