The Food Safety Authority of Ireland (FSAI) today warned hospitals and pharmacies to immediately remove an infant formula from their shelves.
Pregestimil, a specialist milk formula for premature infants, has been associated with a number of infant deaths. In December last year the manufacturers Mead Johnson Nutritionalsa began a global voluntary product recall.
Although the implicated batches were not distributed in Ireland, the FSAI said that limited quantities of the formula could be still available in some hospitals and 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 the deaths of two babies 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.
To make sure that all Pregestimil has been fully recalled, the FSAI is enlisting assistance from environmental health officers, the National Disease Surveillance Centre and the Irish Medicines Board to alert chemist shops, pharmaceutical wholesalers and the medical profession.
Dr John O'Brien, Chief Executive of the FSAI ,said the 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 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," he said.
Those with concerns or queries regarding the product can contact the FSAI helpline on 1890-336677 from 9 a.m. to 5 p.m., Monday to Friday.