The Food and Drug Administration (FDA) has found evidence of quality control issues in its probe of the Abbott baby formula facility in Sturgis, MI.
No Control System at Abbott Baby Formula Facility
The FDA announced the results of its probe into Abbott Laboratories’ Michigan baby formula plant on March 22, 2022. The agency discovered Cronobacter sakazakii on the surface of some areas producing the company’s powdered baby formula. The bacteria can cause meningitis or other life-threatening invasive infections, as well as premature infant death. A Cronobacter infection may also spread to other parts of the body and damage the bowels.
Reports that the facility’s products had been linked to bacterial infections forced Abbott to begin recalling some of its Alimentum, Similac, and EleCare baby formula products earlier in the year, prompting the FDA probe, which ran from Jan. 31 to March 18, 2022.
The inspection found that there was no control system covering all stages of processing to prevent microbe contamination at the Abbott baby formula facility. The FDA also discovered that personnel working with infant formula did not wear the appropriate protective apparel.
FDA Issues Safety Warning for Consumers
The FDA has warned consumers not to use Similac, Alimentum, or EleCare formulas if:
- The first two digits of the lot code on the container are 22 through 37;
- The code on the container contains K8, SH, or Z2; and
- The expiration date is April 1, 2022 or later.
Consumers also should not use Similac PM 60/40 with the lot code 27032K80 on a can or 27032K800 on a case. Parents who are worried about their children’s health after ingesting these products should contact their physicians. Additionally, they may check Abbott’s website to see if they have recalled formula in their possession.
Lawsuits Filed Over Baby Formula Infections
In response to the FDA’s report, Abbott said in a statement that “We’re taking this very seriously and are working closely with the FDA to implement corrective actions.”
The company also insisted that Cronobacter sakazakii was not found during the company’s testing of products that were distributed to consumers and that the genetic makeup of the bacteria found at the Abbott baby formula facility in Michigan did not match that of the reported cases of infant infection.
Plaintiffs have filed at least half a dozen lawsuits in the U.S. District Court for the Northern District of Illinois against the company, which is based in north suburban Abbott Park. The lawsuits so far have sought class-action status, alleging that Abbott did not warn consumers about the risks of feeding its powdered baby formula to babies prior to purchase and did not replace the recalled products promptly.
The litigants filed suit after several babies who allegedly consumed Abbott’s baby formula were hospitalized from Cronobacter sakazakii and Salmonella Newport infections. At least one of these infants has since died. It is unknown whether any of those children’s families have retained personal injury attorneys.
Helping People Hurt By Dangerous Products
To learn more about your legal options if a dangerous product has harmed you or your loved ones, reach out to the personal injury attorneys at GWC Injury Lawyers LLC today.
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