Nutricia has spoken out after Cronobacter was found in Australian tests of infant formula made in Europe.
One lot of KetoCal 3:1 tested positive for Cronobacter spp. after being sampled at the border by Australian customs officials as part of random routine testing. There have been no known related illnesses. Nutricia said the batch was negative before leaving the production facility and further testing also failed to find Cronobacter.
The formula at issue is a specialty medical nutrition product intended for the dietary management of drug-resistant epilepsy, or where a ketogenic diet is indicated by a healthcare practitioner. It is made in Europe and is not sold to the general public but is available on prescription.
The boxes concerned carry the batch number 101101598, to be consumed preferably before July 8, 2023.
In a letter to healthcare professionals in Australia dated April 29, Nutricia, which is owned by Danone, said there were 600 boxes of the affected lot available in Australia and the next shipment of 800 boxes of this lot was due to arrive. around May 23. A new batch from Europe has been ordered with an expected arrival on May 7th.
A Nutricia spokesperson said Food Safety News it is committed to providing customers with the highest quality products.
“That’s why our products go through rigorous testing before they go on sale. During a recent routine random test of special medical infant formula imported by Australian authorities, a naturally occurring bacterium, known as Cronobacter, was detected in a specific lot of our KetoCal 3:1 product that had been exported to Australia from our company. plant in Europe. In accordance with our food safety policies, before being released for sale, the lot also underwent microbiological testing for the presence of Cronobacter, and the lot tested negative before leaving our factory,” the spokesperson said. .
Danone said the issue did not affect the formula in the US market.
Approved with new instructions
After being informed of the test results, the company notified the relevant health agencies in Australia, according to the spokesperson.
“The Australian authorities subsequently approved the batch for use with specific instructions for the preparation of the product. These instructions call for mixing the product with water at a temperature of 80 degrees C (176 degrees F), which would kill any Cronobacter if potentially present,” they said.
“We have not received any adverse reports from patients or their families following consumption of the affected lot and we have also performed additional testing on the affected lot which did not show any presence of Cronobacter in these products. No other KetoCal 3:1 lots and no other KetoCal products are affected.
Cronobacter infection in infants usually begins with fever and poor feeding, excessive crying, grunting while breathing, or very low energy. Some may also have seizures. If your child develops these symptoms, take him to a doctor as soon as possible. People most likely to get sick from Cronobacter infections include infants 2 months and younger, those born prematurely, or those with weakened immune systems, such as those undergoing chemotherapy.
People have been advised not to change or discontinue their child’s formula without consulting their pediatrician, neurologist, metabolic doctor, or dietitian.
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