Food authority calls for removal of infant formula Pregestimil

The Food Safety Authority of Ireland (FSAI) today advised hospitals and pharmacies that may still have stocks of the infant formula Pregestimil to immediately remove it from use.

Pregestimil is a specialist milk formula for premature infants.

At the end of December last, a number of batches were associated with serious illness which triggered a global voluntary product recall of all batches of Pregestimil by manufacturers Mead Johnson Nutritionals.

Although the implicated batches were not distributed in Ireland, it has come to the attention of the FSAI that limited quantities of the formula could be still available in some hospitals and/or pharmacies.

The company has confirmed to the FSAI that the implicated batches of the formula were only distributed to Algeria and France. However, as a precautionary measure, the FSAI is asking all hospitals and pharmacies not to use the product and remove it from use.

The global recall was initiated by the manufacturers after batches of the product were associated with two infant deaths in France. The deaths were due to Enterobacter sakazakii, a pathogen that can cause serious infection in vulnerable infants, but poses little risk to healthy, full-term infants.

Dr John O'Brien, Chief Executive, FSAI stated that this recall is a precautionary measure and that parents of premature babies should not be unduly alarmed. Those who have concerns should contact their medical practitioner for advice.

"This product is very specialised and is adapted for premature babies with intolerance to cow's milk protein. As such, it was only available in hospitals and a limited number of pharmacies. It was not available in shops or supermarkets," he said.

"The company has assured us that the implicated batches were never distributed on the Irish market. However, for maximum safety all batches of the Pregestimil are being recalled worldwide. I would advise any parent who may have a can of Pregestimil in their home not use it and to return it to its point of supply, be it the hospital or their pharmacy."