Dubai, United Arab Emirates (CNN) – The US Food and Drug Administration announced that a company that manufactures infant formula is under investigation after complaints from consumers that it caused a disease in children, and that it will consider distributing each product separately.
The U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention are currently researching Abbott Nutrition infant formula products.
The company has recalled Similac, Alimentum and EleCare products produced at its facility in Sturgis, Michigan, while they are undergoing safety tests, and the milk recall has exacerbated product shortages due to supply chain problems.
Because the tests would take time, the FDA said it had “no objection” to Abbott distributing products immediately to “individuals who need an urgent supply” of some infant formula on a case-by-case basis.
The agency said: “The US Food and Drug Administration is concerned that the unavailability of some infant formula products will significantly exacerbate underlying medical conditions, especially as they sometimes threaten the lives of infants and the individuals who depend on them.”
“In these circumstances, the benefit of allowing parents to consult with health care providers to access these products may outweigh the potential risk of bacterial infection,” she added.
And the US Food and Drug Administration stressed that the products manufactured in the company’s facility from late January to early March, that is, before being examined by the Food and Drug Administration, may carry a risk of infection, and indicated that parents who are looking for infant formula should contact a doctor their children about whether the benefit of consuming this formula outweighs the risk of bacterial infection in their child’s condition.
In a statement issued Friday, the company said it was “distributing limited quantities of metabolic feeding formulas at the request of the Food and Drug Administration that were previously suspended, after Abbott recalled some infant formula milk from its facility in Sturgis, Michigan. The products have been tested, which are: Complies with all pre-distribution product release requirements. Refunds are also not included.
The US Food and Drug Administration stated that parents seeking to obtain the product should contact Abbott directly to request it. The company said the products will be distributed free of charge to patients in coordination with healthcare professionals.
“We understand that every patient who relies on these critical products has critical needs, and we are working hard to get the product to as many patients as possible,” the statement said.
The infant formula that can be distributed on a case-by-case basis is as follows:
Glutarex-1، وGlutarex-2، وCyclinex-1، وCyclinex-2، وHominex-1، وHominex-2، وI-Valex-1،Valex-2 Ketonex-1،Ketonex-2 ،Phenex-1 ،Phenex-2 ،Phenex-2 Vanilla ،Pro-Phree ،Propimex-1 ،Propimex-2 ، ،ProViMin ،Calcilo XD ،Tyrex-1 ،Tyrex -2 وSimilac PM 60/40.
The infant formula, which was withdrawn from circulation earlier this year, was linked to serious infections caused by the bacteria Cronobacter sakazakii and Salmonella in 5 children, two of whom died from Cronobacter.
In the statement, Abbott indicated that no infant formula was distributed to consumers that tested positive for Cronobacter sakazakii or salmonella, and that testing of products withheld by the Food and Drug Administration came back negative for the presence of Cronobacter sakazakii and/or salmonella. The company also said that no salmonella was found at the facility during the investigation, and that Cronobacter sakazakii found was in non-production areas and has not been linked to an infant contracting a known disease.
Abbott’s statement concluded that “a comprehensive review of all available data indicates that infant formula produced at the Sturgis facility is unlikely to have been the source of infection in the reported cases, and that there was no outbreak resulting from products manufactured in the facility.”