Thursday 28 March 2024
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Recall after human breast milk sold to hospitals may contain elevated lead content

The Food Standards Agency (FSA) is working with Trading Standards to investigate how human breast milk products made by NeoKare Nutrition Limited contained elevated levels of lead.

The Department of Health and Social Care, UK Health Security Agency, NHS England, Welsh Government, Public Health Wales, NHS Wales and Food Standards Scotland (FSS) are also supporting the FSA in their response.

The company sold a small number of human breast milk products to people online. Thirteen hospitals were also supplied by the company. Of those supplied, 7 hospitals used the product – 6 in England and 1 in Wales. One of the products was given by some hospitals to a small number of premature babies as part of a clinical trial or as an alternative source of nutrition.

NeoKare would like to add some context to the NeoKare Precautionary recall issued for its products:
  • There is an environmental amount of baseline lead present in human milk
  • The Local Authority are conducting ongoing tests with the full support of NeoKare on raw milk, pooled milk and finished product to build a quantum of data to help understand the amounts of lead present
  • This recall is subject to the UK
  • This is a precautionary recall as the risk has been deemed low

On the advice of Trading Standards and the FSA, all the products sold by the company have been withdrawn and recalled by the business as a precaution. A small number of customers who purchased the affected products online have been notified by the company.

The small number of families whose children had been given some of the affected products have been contacted by the NHS. The risk to the health of those who have been given these products is likely to be low.

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Only commercial products made by NeoKare Nutrition Limited are affected by the recall. No other human breast milk or baby formula products on sale to the public are included in the recall and donor human breast milk from not-for-profit milk banks is unaffected.

Junior Johnson, Director of Operations at the Food Standards Agency said:

‘This situation is understandably worrying for the parents and guardians affected. We have worked closely with the public health authorities and the NHS to assess the risk to health, which is likely to be low.

‘Following advice from FSA and Trading Standards, the business recalled the products and we’ve ensured that customers and patients are contacted. Additional support has been offered to retail customers and to families whose children were given the products.

‘We continue to work with Trading Standards to ensure there is no further food safety risk to the public.’

Risk to consumers

 The FSA, working the UK Health Security Agency (UKHSA) and the NHS have conducted a risk assessment which has established that the actual levels and duration of use of these products varies. Exposure to lead from these products is likely to have been for a short period of time. Adverse effects from lead typically arise from repeated exposure over an extended period of time, so the risk to children from this product is low.

Advice to consumers

 We have identified that you have been supplied with one or more of the products mentioned above. If you have received it, do not feed it to your baby. Most of the products are out of date, however, in case you have not observed the durability date, do not feed it to your baby. Instead, contact enquiry@neokare.co.uk for a full refund.

We have provided the details of all the recipients of our products to the UKHSA who will make contact with people we have supplied, and they will also inform their GP.

 

 

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