The Food and Drug Administration is allowing Abbott Nutrition to release limited amounts of certain infant formulas made at a plant under investigation in relation to an outbreak of cronobacter infections.
“The FDA is concerned that the risk of not having certain specialty and metabolic products available could significantly worsen underlying medical conditions and in some cases pose life-threatening risks for infants and individuals who rely on these products,” according to a statement released to Food Safety News. “In these circumstances, the benefit of allowing parents, in consultation with their healthcare providers, to access these products may outweigh the potential risk of bacterial infection.”
Abbott has confirmed with the FDA that the company will consider release of these products on a case-by-case basis, depending on product availability and the severity of the individual’s need. Patients and caregivers seeking access to these products may contact Abbott directly to request that a product be made available to them by calling 800-881-0876.
An Abbott spokesperson told Food Safety News: “Products will be released free of charge to patients in coordination with healthcare professionals.”
There have been complaints from people across the country who say they have not been able to find replacements for the Abbott-produced formula and stores have reported empty shelves.
The specialty and metabolic formulas that may be released on a case-by-case basis are:
- Glutarex-1
- Glutarex-2
- Cyclinex-1
- Cyclinex-2
- Hominex-1
- Hominex-2
- I-Valex-1
- I-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
- Similac PM 60/40
The FDA and the Centers for Disease Control and Prevention (CDC) are continuing to work with state and local public health officials to investigate the outbreak that has sickened four babies, killing two. The statement released today stresses that parents and caregivers should check with their doctors to make sure the risk of using the formula produced at Abbott’s Sturgis, MI, facility outweighs the risk of possible infection.
“It is important for parents and caregivers to understand that any products released on a case-by-case basis at this time were made at Abbott Nutrition’s Sturgis, MI, facility, and that the processes, procedures, and conditions that the FDA observed during its inspection of the Sturgis MI production facility from January 31 – March 3, 2022, raise concerns that powdered infant formula produced at this facility prior to the FDA’s inspection carry a risk of contamination,” according to the FDA statement today.
The FDA received reports of sick infants from Sept. 20, 2021 through Jan. 11, 2022. The agency initiated investigations at the Abbott facility on Jan. 31 and a product recall was initiated in mid-February. All four sick infants ate infant formula produced at the Sturgis facility.
“While the FDA recognizes that Abbott has conducted standard product testing, there were a limited number of samples tested. Additionally, although finished product testing does not eliminate the risk of contamination, the enhanced testing will provide for a greater chance to detect Cronobacter sakazakii, if present; however, this enhanced level of testing will take additional time,” the FDA statement says.
Parents and caregivers who obtain the special Abbott products on a case-by-case basis should carefully follow Abbott’s preparation instructions as indicated on the product container, according to the FDA. Parents and caregiver should pay close attention to the user’s health status and alert a healthcare provider immediately of any change in health status. In the meantime, the FDA is continuing to work diligently to ensure the safe resumption of production of infant formula at Abbott Nutrition’s Sturgis facility.
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