Abbott Nutrition, the food processing division of pharmaceutical giant Abbott Laboratories, was cleared by the Food and Drug Administration to resume production of baby formula.
On Saturday, June 4, Abbott announced that the first batches of its specialty formula started rolling out over the weekend at its Michigan plant.
A nationwide shortage of baby formula has impacted the United States since May and will likely last a few more weeks, but Abbott expects the formula to become available to consumers on or around June 20.
According to executives from Abbott Laboratories, the first item under production at the Sturgis, Michigan, plant is the EleCare line of baby formula, designed for infants with specific food allergies.
The product requires more supervision and quality control. It will take the company about two months to re-attain its previous pace of operations.
The Abbott Nutrition plant in Sturgis stopped production after infants who had consumed formula from the facility became ill, though the sicknesses are not confirmed to have been caused by Abbott products.
Pediatricians who treated the first cases ordered laboratory diagnostics that came back positive for Cronobacter sakazakii, a common environmental bacterial pathogen that can rapidly enter the bloodstream upon ingestion. Cronobacter infections in babies can lead to sepsis and meningitis.
Abbott issued a recall of some of its baby formula brands soon after the announcement of the first hospitalizations. Four babies became ill and were hospitalized after consuming formula manufactured at the Sturgis facility; two infants eventually recovered, and two infants passed away.
Following an investigation by the FDA and Abbott Nutrition, the company issued a statement claiming that there is no evidence linking its formulas to these infant illnesses.
Specific product lots were believed to be the source of the problem, but further inspections concluded that while Cronobacter sakazakii was discovered in the manufacturing facility’s environment, the bacteria was not found in an area where it could contaminate the baby formula.
The Abbott website notes that genetic sequencing on the two available samples from ill infants did not match strains of Cronobacter in the plant, meaning there was no connection between the two cases.
In all four cases, the babies’ unopened formula samples were tested for Cronobacter by the state, FDA, or CDC, and all containers were negative. Officials also tested open containers from the four babies’ homes, and three tested negative. The one positive sample from an open container in the fourth baby’s home revealed the presence of two different strains of Cronobacter sakazakii.
One of the strains of bacteria matched the strain that caused the baby’s infection, and the other matched a strain found on a bottle of distilled water in the home used to mix the formula, but neither was the same as the strains found in the plant.
The babies had consumed four different kinds of formula that Abbott manufactured over the course of almost a year, and the illnesses occurred in three states over several months.