Abbott provides infant formula update

May 17, 2022

Abbott announced in a press release they have been working with the United States Department of Agriculture (USDA) and Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) agencies and paying rebates on competitive products in states where Abbott holds the WIC contract, when Similac is not available.

Abbott will continue to pay rebates for competitive products through August 31. This means program participants will continue to be able to obtain formula, free of charge whether it is Similac or formula from another manufacturer.

Abbott acknowledges that the recall has worsened the industry-wide infant formula shortage, and we have been working to get as much product into the hands of parents as we can.

Since February:

  •  Abbott says they have shipped millions of cans of infant formula powder into the U.S. from our FDA-registered facility in Cootehill, Ireland.
  • They have prioritized infant formula production at their Columbus, Ohio, facility, converting other liquid manufacturing lines into manufacturing Similac liquid ready-to-feed.
  •  They are offering an increased number and value of coupons available for all our infant formula products, including Similac ready-to-feed, to enable customers to purchase formula, either free or deeply discounted.
  • And our other manufacturing facilities are running at full capacity as they continue to prioritize production of infant formula to help replenish the supply in the market.

At the same time, they are working to address the FDA’s 483 observations so they can restart operations at the Sturgis, MI facility.  They also they could immediately began implementing corrective actions and subject to FDA approval, and restart the Sturgis, MI site within two weeks.

The following provides current information on the findings from the investigation, our Sturgis, Mich., facility and supply.

The February voluntary recall involved four complaints of Cronobacter sakazakii — a common environmental bacteria — in infants who consumed infant formulas produced in this plant. Two infants became sick; two tragically passed away.

The facts about what was learned about the cases of Cronobacter have not been widely communicated. After a thorough review of all available data, there is no evidence to link our formulas to these infant illnesses.

It's important to know:

  • Abbott conducts microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella.
  • All finished product testing by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter and/or Salmonella. No Salmonella was found at the Sturgis facility.
  • The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of the facility and has not been linked to any known infant illness.

Specifically:

  • Genetic sequencing on the two available samples from ill infants did not match strains of Cronobacter in our plant. Samples from ill infants did not match each other, meaning there was no connection between the two cases.
  • In all four cases, the state, FDA, and/or CDC tested samples of the Abbott formula that was used by the child. In all four cases, all unopened containers tested negative.
  • Open containers from the homes of the infants were also tested in three of the four cases; two of the three tested negative. The one positive was from an open container from the home of the infant, and it tested positive for two different strains of Cronobacter sakazakii, one of which matched the strain that caused the infant’s infection, and the other matched a strain found on a bottle of distilled water in the home used to mix the formula. Again, neither strain matched strains found in our plant.
  • The infants consumed four different types of our formula made over the course of nearly a year and the illnesses took place over several months in three different states.

Regarding the status of our work to reopen Sturgis:

The FDA concluded its inspection with a 483 letter to Abbott on March 18. This is a list of observations.

Abbott release

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