August 14, 2022

FDA Updates Abbott Nutrition Powdered Infant Formula Cronobacter Issue

The FDA has updated its investigation into the Abbott Nutrition powdered infant formula Cronobacter issues. The investigation into the contamination continues, along with the investigation of consumer complaints and reports of human illness allegedly related to products from the company’s Sturgis, Michigan facility.

FDA Updates Abbott Nutrition Powdered Infant Formula Cronobacter Issue

Abbott has “has committed to completing enhanced testing of stored product batches prior to making release determinations.” The FDA recognizes that Abbott has conducted “standard product testing,” but there were a limited number of samples tested. The FDA also stated that 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 has no objection to the company releasing product to people needing urgent, life-sustaining samples of specialty and metabolic formulas on a case-by-case basis. The FDA thinks that the risk of not having these products could “significantly worsen” underlying medical conditions and in some cases pose life-threatening risks for infants and people who rely on these products. The benefit of allowing parents, in consultation with doctors, to access these products may outweigh the potential risk of bacterial infection.

Abbott has confirmed that they will consider release of these products, depending on product availability and the severity of the individual need. To contact Abbott to request that a product be made available, call 1-800-881-0876.

Considerations for parents requesting specialty Abbott Nutrition powdered infant formula

If you do request a specialty Abbott Nutrition powdered infant formula, consult with your doctor about the benefit and risks of feeding these products to your child. The FDA states, “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.”

And if you do get these formulas, carefully follow preparation instructions and ask your doctor about the best method of preparation.

Abbott confirmed on May 1st that they will be releasing limited quantities of metabolic nutrition formulas that were previously on hold. According to Abbott’s statement the lots being released were not included in the previous recall. These products are used under the care of a healthcare professional and require a medical referral. To contact Abbott to request that a product be made available, patients and caregivers should call 1-800-881-0876.
The metabolic products being released are:
  • Calcilo XD®
  • Cyclinex®-1 and 2
  • Glutarex®-1 and 2
  • Hominex®-1 and 2
  • I-Valex®-1 and 2
  • Ketonex®-1 and 2
  • Phenex®-1 and 2
  • Pro-Phree®
  • Propimex®-1 and 2
  • ProViMin®
  • Tyrex®-1 and 2
The specialty product being released is:
  • Similac® PM 60/40

The recalls of Abbott Nutrition powdered infant formula

The recall of Abbott Nutrition powdered infant formula remains in effect. Similac, Alimentum, and ElCare formulas that are part of this recall have the first two digits of the code 22 through 37, contains K8, Sh, r Z2, and the expiration date is April 1, 2022 or later.

Abbott has also recalled Similac PM 60/40 with a lot code 27032K80 for the can. This is the only type and lot of this specialty product that is recalled.

Latest information on the illnesses

On March 31, 2022, the FDA stated that environmental samples collected from Abbott’s Sturgis, Michigan plant were positive for Cronobacter sakazakii. But product samples collected by the FDA at that facility were negative for Cronobacter.

In addition, the samples taken from sick infants did not match the multiple strains of Cronobacter found at the abbott facility. And the strains from the two infants tested did not match each other.

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