The Nutricia company has spoken out after Cronobacter was found during Australian testing of infant formula made in Europe.

A batch of KetoCal 3:1 was 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 plant and additional testing also did not find Cronobacter.

The implicated formula is a specialized medical nutrition product intended for the dietary management of drug resistant epilepsy, or wher a ketogenic diet is indicated by a healthcare professional. It is manufactured in Europe and not sold to the general public but is available by prescription.

Affected tins are batch number 101101598 with best 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 tins of the affected batch available in Australia and the next shipment of 800 tins from this batch was scheduled to arrive around May 23. A new batch from Europe has been ordered with an expected arrival of May 7.

A Nutricia spokesperson told Food Safety News it was committed to providing customers with the highest quality products.

“That’s why our products undergo rigorous testing before being released for sale. During a recent routine, random product test on imported special medical infant formulas by authorities in Australia, a naturally occurring bacterium, known as Cronobacter, was detected in one specific batch of our KetoCal 3:1 product that had been exported to Australia from our company’s plant in Europe. As per our food safety policies, before being released for sale, the batch also underwent microbiological testing for the presence of Cronobacter, and the batch tested negative before leaving our plant,” the spokesperson said.

Danone said the issue does not impact formula on the U.S. market.

Approved with new instructions
After being told about the test results, the company informed the relevant health agencies in Australia, according to the spokesperson.

“The Australian authorities subsequently approved the batch for use with specific instructions in preparing 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 from consuming the affected batch and we also carried out additional testing of the affected batch, which showed no presence of Cronobacter in these products. No other KetoCal 3:1 batches and no other KetoCal products are affected.”

Cronobacter infection in infants will usually start with a 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 them to a doctor as soon as possible. Those more likely to get sick from Cronobacter infections include infants 2 months and younger, those born prematurely or with weakened immune systems, such as those undergoing chemotherapy.

People were advised not change or stop their child’s formula without consulting their specialist pediatrician, neurologist, metabolic physician or dietitian.