Editor’s Note: This was originally published by eFoodAlert and has been republished here with permission from the writer.
From December 1st, 2021 between March 3 and March 3 2022, US Food and Drug Administration (FDA) received nine (9) reports of infant deaths in babies who were fed infant powder formula made by Abbott Nutrition in Sturgis, Michigan.
The reports of infant deaths were included in a listing that contained 128 complaints from consumers provided to the eFoodAlert through the FDA in response to an Freedom of Information Act (FOIA) request. (see: Abbott Nutrition consumer complaints file, Redacted)
Two of the deaths were listed in the four confirmed incidents of Cronobacter sakazakii that were identified through the US Centers for Disease Control and Prevention (CDC).
The remaining seven deaths have been reported to FDA through the FDA’s consumer complaint process. Two of the complaints mentioned Salmonella in the description of the complaint.
Alongside the deaths of nine, customers reported the following twenty five (25) incidents classified as “Life Risking Injury or Illness” along with Eighty (80) incidents of “Non-Life Injuries or Illnesses that Threaten Life.”
Thirteen people reached out to the FDA to request details or clarifications regarding this recall. Abbott recall.
The complaints were filed with FDA District Offices throughout the continent of the USA.
Salmonella was found in the deaths of two infants, and was also mentioned in 17 other complaints of illness.
One of the infants who survived was infected with Salmonella as well as E. coli.
The symptoms of babies were generally consistent with an gastrointestinal infection. These included symptoms included fever (31 babies) nausea (42 babies) and diarrhea (47 babies) and blood in stool (6). A majority of infants suffered from several symptoms.
Other reported symptoms include an appetite loss as well as rashes (either scattered or localized over the all body) as well as lethargy, dehydration as well as irritability, weight loss, and breathing difficulties.
The infants who were ill were infected with multiple diseases:
The FDA did not respond to eFoodAlert‘s request for comment on what had been carried out to follow-up with regard to the infant fatality reports that didn’t involve C. sakazakii, or Cronobacter as well as on non-fatal illnesses that did not involve any Cronobacter.
According to a spokesperson from the agency The FDA together with the CDC as well as local and state partners examined consumer complaints and/or reports received between September 20, 2021 through the 24th of February, 2022. of infant illnesses.
The spokesperson didn’t discuss all of the over 30 complaints, including three deaths reported through FDA District offices from February 25th, 2022 until March 3, 2022.
Two of the three deaths were attributed to Salmonella.
A FDA inquiry revealed numerous incidents in the presence of The bacterium, Cronobacter sakazakii in the vicinity at Abbott’s facility for manufacturing.
The cultures collected from environmental samples was an exact genetic match to the strain that affected the two babies from whom they were infected. CDC was provided with the cultures. They CDC was not able to receive any cultures from the other two affected babies to conduct genetic analyses.
While there is no definitive evidence from genome sequencing to connect any of the ailments unambiguously in Abbott’s baby formulas each complaint has one thing that they share.
Each affected baby received the Abbott Powdered Formula.
The FDA has set up the Incident Management Group (IMG) under Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response.
The IMG is responsible for managing an ongoing probe and keeping track of the chain of supply for infant formula and will continue to do so at a minimum until the current shortage of supplies is gone as per the FDA spokesperson.
Production has resumed under closely monitored conditions at Abbott Nutrition’s Abbott Nutrition plant in Sturgis The time has come to remember the loss of lives.
We have no information about the nine babies who passed away. Because of privacy concerns their names and the ages, genders, locations they resided and the date they passed away have been kept private. They can be identified by their distinctive Complaint identification numbers.
The complaint ID is #171222 published on 1st December 2021. Infant arrived to the ER in cardiac arrest. Cronobacter Sakazakii as well as Proteus mirabilis. The infant had consumed Similac Pro-Total Comfort (Powder) infant formula Lot #23495K80.
Complaint ID 172435, received February 22nd 2022. Vomiting, swollen organs, difficulty breathing. The infant consumed Similac Advance Lot #34875K80.
Complaint ID #172477 filed February 22nd 2022. Screaming. Infant had consumed Similac Total Comfort Easy-to-Digest Gentle Protein & Prebiotics, et al, infant formula powder, Lot #34869K80.
Complaint ID 172479, filed 23 February 2022. Diarrhea, fever and loss of appetite. vomiting. Infant consumed Similac Infant formula Advanced. Lot number is not readily available.
The complaint ID is #172541. received on February 24, 2022. Tested positive for Cronobacter sakazakii. The infant consumed Similac PM 60/40 Lot #27032K800.
Complaint ID #172585 received 24 February 2022. No details available. Infant was fed EleCare infant formula. Lot number not available.
Complaint ID #172607 filed February 28th 2022. Cause of death and diagnosis pending further investigations (Congenital). Infant consumed Similac Elcare infant powder Lot #34771Z21 130635
Complaint ID #172632, reported March 2, 2022. Salmonella meningitis, ventriculitis, vomit, diarrhea, seizures, bradycardia. The infant had eaten Similac Pro Infant formula Advance Lot #25598SHO, 200557 015 SIMESPWD.
Complaint ID #172636, reported March 2, 2022. Salmonella. The infant had eaten Similac Total Comfort Lot # 26834K80.
Let them rest peacefully.