FDA allows release of Abbott Nutrition’s recalled products in “urgent cases”

04 May 2022 --- The US Food and Drug Administration (FDA) does not object to the release of Abbott Nutrition’s previously recalled products, including Similac, Alimentum and EleCare powdered formulas, to individuals in need of urgent, life-sustaining supplies of specific specialty and metabolic formulas.

The items were manufactured at Abbott’s US-based Michigan factory and voluntarily recalled by the company following an FDA warning about the use of powdered infant formula products produced at this factory.

A subsequent FDA investigation of the plant identified five environmental subsamples positive for Cronobacter sakazakii.

Responding to the announcement, Abbott outlines: “the products have been tested and comply with all product release requirements before distribution. The lots being released were not included in the recall.”

The benefits may outweigh the risk
The FDA allows for the release of Abbott’s previously recalled products as some consumers may be unable to obtain some specialty and metabolic products, which could exacerbate underlying medical issues.

The FDA decision comes as the US is facing infant nutrition shortages.The agency adds that in some instances, the unavailability of these products may constitute a life-threatening threat to those who rely on them. In these cases, allowing parents, in consultation with their healthcare providers, to access these products may outweigh the potential risk of bacterial infection.

Abbott acknowledged that, depending on product availability and the severity of the individual’s need, the company would consider releasing these products case-by-case.

The FDA adds that anyone wanting access to these products should contact their healthcare professional to evaluate if the benefit of taking such a product outweighs the danger of bacterial infection in their specific situation.

Steps toward releasing products
Patients and caregivers who want access to these products may contact the company and request that a product be available.

Addressing the voluntary product recall, executive vice president of nutritional products at Abbott, Joe Manning, says: “We know parents depend on us to provide them with the highest quality nutrition formulas.”

“We’re taking this action so parents know they can trust us to meet our high standards and theirs. We deeply regret the concern and inconvenience this situation will cause parents, caregivers and health care professionals.”

The FDA states that parents and caregivers should be aware that any products released on a case-by-case basis were manufactured at Abbott Nutrition’s Sturgis facility.

Additionally, the FDA’s processes, procedures and conditions during its inspection of this specific production facility raise concerns that powdered infant formula produced before the FDA’s inspection may be contaminated, the agency notes.

As the US experiences a severe shortage of infant formula, Abbott Nutrition is ramping up infant formula production while working with the FDA to reopen its Sturgis, Michigan, factory.

Edited by Nicole Kerr