Following the death of an infant and the hospitalization of three others in the United States, the Israeli importer of Abbott, one of the largest infant formula makers in the US, announced Sunday a recall of two products, Similac’s Alimentum and Human Milk Fortifier, after they were recalled in the US last week.
Alimentum is sold under prescription in pharmacies, and cannot be found on supermarket aisles. Human Milk Fortifier is found in prenatal units at hospitals, and given only under prescription.
The importer said that it would collect about 700 units of the Abbott products as a precautionary measure, following a warning from the US Food and Drug Administration, as these were produced in the Michigan plant highlighted in the US recall.
The FDA said last week that it was investigating four reports of infants who were hospitalized after consuming the formula, including one who died. The agency said one of the cases involved salmonella and three involved Cronobacter sakazakii, a rare but dangerous germ that can cause blood infections and other serious complications.
“We know parents depend on us to provide them with the highest quality nutrition formulas,” Joe Manning, the executive vice president of nutritional products at Abbott, said in a statement. “We deeply regret the concern and inconvenience this situation will cause parents, caregivers and health care professionals.”
The FDA had reported that it received and was investigating complaints of four infant illnesses from three states in the US: Minnesota, Ohio and Texas. They said that in all of the reported cases, the contaminated infant formula was produced in Abbott Nutrition’s Sturgis, Michigan, facility.
“As this is a product used as the sole source of nutrition for many of our nation’s newborns and infants, the FDA is deeply concerned about these reports of bacterial infections,” Frank Yiannas, the FDA deputy commissioner for food policy and response, said in a statement released Thursday.
“We want to reassure the public that we’re working diligently with our partners to investigate complaints related to these products, which we recognize include infant formula produced at this facility, while we work to resolve this safety concern as quickly as possible.”
Abbott in the US said it was recalling all potentially affected products manufactured at the facility. The recall affects certain lots of Similac, Alimentum and EleCare with expiration dates of April 1, 2022 or later. The product was distributed throughout the US and overseas, the company said in a statement.
Abbott said parents can identify the recalled products by examining the number on the bottom of each container. The affected formulas have a number starting with 22 through 37, contain K8, SH, or Z2 and have an expiration date of April 1, 2022 or later.
Abbott’s Israeli importer stressed there was no connection to other Abbott products distributed in Israel, including Similac products. None of the products distributed was found to be positive for the presence of Chronobacter sakazakii or Salmonella Newport in the manufacturer’s tests prior to release, the importer said. The products were also tested and approved by the Ministry of Health after their arrival in Israel.
To Israelis, the recall was a reminder of the Remedia baby formula affair. Four babies died and dozens suffered permanent damage to their nervous systems after consuming non-dairy vegetarian formula under the Remedia label sold between July 2003 and November 2003 that did not contain B1, which is essential to a baby’s development.
Michal Gazber, whose child was impacted by the Remedia affair, told Radio 103FM: “There is always fear. I was sent a link to the article and started shaking — this is really PTSD.”
Agencies contributed to this report.