Abbot and FDA were warned a year before the recall about formula plant conditions

Abbot and FDA were warned a year before the recall about formula plant conditions

The Wall Street Journal confirmed that Abbott, the manufacturer of the recalled formula, as early as February 2021.

A former Sturgis, Michigan Abbott plant employee, filed a complaint with the US Department of Labor Occupation Safety and Health Administration (OSHA) on February 16, 2021, which OSHA then passed on to the Food and Drug Administration (FDA) and Abbott days later. The Whistleblower then filed another complaint with the FDA, which expanded on February 16, 2021, and described the conditions at the plant in greater detail. The complaint made October 2021 was released to the public in April 2022 by US Rep. Rosa DeLauro.

The October 2021 report stated that there were ongoing problems with the integrity of the seals on the powered products and that there was no set of standards or processes to verify ussies had been fixed, employees in the facility consciously evaded oversight of quality control processes, falsified records regularly and did not follow proper procedures for sanitizing equipment. Aside from the whistleblower complaints, FDA records also confirm that the Sturgis Michigan plant had also had Cronobacter Sakazakii present during a September 2019 inspection. The FDA proceeded to alert Abbott that its employees had failed to test a batch of Similac formula for Salmonella following Abbott company policies. Although the FDA Inspectors had found Cronobacter Sakazakii, they would not return until September 2021, when another notice was issued for failing to maintain a clean and safe building.

In December 2021, the FDA interviewed the Whistleblower, and following the interview, they found cause to complete an in-person inspection of the facility between January and March 2022. The January 31, 2022, inspection that led to the facility’s shutdown found issues such as a leaking roof, standing water, cracks in equipment that could lead to bacterial contamination, and Cronobacter sakazakii bacteria growing in multiple locations.

Abbott Formula Recall

9 reports of infant deaths were made against Abbott nutrition between December 1, 2021, and March 3, 2022, along with 119 complaints ranging from mild to severe and life-threatening infections. According to the Complaint Document the, some of the babies suffered from more than 1 infection, including:

  • Cronobacter sakazakii and Proteus mirabilis
  • Covid-19 and Salmonella
  • CDIFF (Clostridioides difficile) and Salmonella
  • Salmonells and Shigells
  • Salmonella, astrovirus, and “shigelloides.”

Abbott announced that there would be a voluntary recall of products that may have been contaminated, including Similac, Alimentum, and EleCare powdered formulas made in the Sturgis Michigan facility. Illnesses confirmed due to the recall were confirmed in 4 states, including Ohio, Texas, and Minnesota. The recall included formulas with the following labeling information

  • the first two digits of the code are 22 through 37; and
  • the code on the container contains K8, SH, or Z2; and
  • the expiration date is 4-1-2022 (APR 2022) or later.

Signs of Illness from the Associated Infections

This recall and investigation are associated with the following illnesses and their symptoms below.

  • Cronobacter can cause severe and life-threatening infections (sepsis) or meningitis (inflammation of the membranes that protect the brain and spine). Symptoms include poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal movements.
  • Salmonella is a group of bacteria that can cause gastrointestinal illness and fever called salmonellosis. Most people develop diarrhea, fever, and abdominal cramps. More severe cases of salmonellosis may include a high fever, aches, lethargy, a rash, and blood in the urine or stool, and it may become fatal in some cases.

You may be eligible for compensation if your baby ingested contaminated formula and became ill. Contact Charles Boyk for a free consultation with one of our attorneys. We fight to get our clients justice when a company’s negligent actions have resulted in an injury or death.

Charles E. Boyk Law Offices, LLC