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May 20, 2022
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FDA Allows Abbott to Release Some Infant Formula Amid Shortage

FDA Allows Abbott to Release Some Infant Formula Amid Shortage

Federal regulators have given permission to Abbott Nutrition to release some of its infant formula included in a recent recall to families who desperately need it on a case-by-case basis.

The formulas were produced at Abbott’s facility in Sturgis, MI, this year and carry a risk of being contaminated, the FDA said. But the company may release products to families “needing urgent, life-sustaining supplies” of certain formulas.

“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,” the agency said in a statement.

“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,” the FDA said.

The specialty and metabolic formulas that can be released on a case-by-case basis include:

  • 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

Patients and caregivers who want to access the products should contact Abbott directly by calling 800-881-0876. Those who receive and use the formulas should follow the preparation instructions listed on the containers and monitor the infant’s health for any changes, the FDA said.

The FDA still warns against using recalled Similac, Alimentum, or EleCare powdered formulas with particular lot codes. The agency also strongly recommends against diluting infant formula, making homemade formula, or buying imported formula online.

Also on Wednesday, Abbott released an update about the investigation of its Sturgis facility. This year, four infants became ill with Cronobacter sakazakii bacteria after consuming infant formula produced in the plant. Two infants died.

“After a thorough review of all available data, there is no evidence to link our formulas to these infant illnesses,” the company said in the statement.

Based on testing before distribution, no Abbott formula sent to consumers tested positive for cronobacter or salmonella, the company said. None of the finished products contained bacteria from either strain, and no salmonella was found at the Sturgis facility. The cronobacter found in environmental testing was in areas that didn’t have contact with products.

Specifically, genetic sequencing from two samples from the ill infants didn’t match the strains of cronobacter found in the Sturgis plant, the company said. The samples from the infants also didn’t match each other, which suggests they aren’t connected.

The FDA and CDC tested samples of the Abbott formula for all four cases among the infants, and all the unopened containers tested negative, the company said. The open containers were also tested, and one positive one had two strains of cronobacter, including one that matched a strain found on a bottle of distilled water in the home used to mix the formula. Neither strain matched the cronobacter strains found in the Sturgis plant.

“We know the recall has worsened an already existing industry-wide infant formula shortage in the U.S., and we’ve been seeing and hearing the stress and despair of parents who are facing empty shelves,” the company wrote.

Subject to FDA approval, Abbott could restart the Sturgis plant within 2 weeks, the company said, beginning with production of EleCare, Alimentum, and metabolic products and then Similac and other formulas. From the time Abbott restarts the site, it’ll take about 6 to 8 weeks before products are on store shelves.

“We understand the situation is urgent,” the company wrote. “Getting Sturgis up and running will help alleviate this shortage.”

SOURCES:

FDA: “FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022),” updated May 11, 2022.

Abbott: “Abbott Provides Infant Formula Update,” May 11, 2022.

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