The recall has led to a shortage of baby milk formula products in the US, and the consent decree has now been amended to get EleCare to children in urgent medical need
Abbott headquarters. (Credit: Abbott)
Abbott has unveiled its plans to release limited quantities of its EleCare speciality amino acid-based formulas after the US District Court has amended the recent consent decree.
In February this year, the company voluntarily recalled some of its powder infant formulas produced at the Sturgis, Michigan facility, and has put the production on hold.
The recall was due to complaints about Cronobacter sakazakii or Salmonella Newport infections in infants who consumed the formula produced at the facility.
The US Food and Drug Administration (FDA) investigated consumer complaints regarding infections.
The recall has led to a shortage of baby milk formula products in the US.
Earlier this month, Abbott signed a consent decree with the US Food and Drug Administration (FDA) to restart infant formula production at its facility in Sturgis, Michigan.
The consent decree has now been amended based on the request of Abbott and the US FDA, to get EleCare to children in urgent medical need.
EleCare formulas are hypoallergenic and are used for feeding infants and children with severe food allergies or gastrointestinal disorders that require amino acid-based formulas.
Abbott stated that all products have been tested and meet all product release requirements, and additional, enhanced testing confirmed that the product is safe to distribute.
The company intends to restart the production at Michigan facility from 4 June 2022, with plans to bring initial EleCare products to consumers by 20 June.
Abbott chairman and chief executive officer Robert B Ford said: “Releasing this product immediately will help families impacted by the lack of availability of EleCare.
“When we restart our Sturgis facility the first week in June, we will produce EleCare first and make enough so that several months of supply will be available.”
In a separate development, the US FDA has updated its regulations to allow additional infant formula imports from the UK.
The US health agency said that it is implementing ‘enforcement discretion’ for the importation of certain infant formula from Kendal Nutricare brand.
The company is expected to initially dispatch around two million cans of infant formula to the US, starting from next month.