Baby food giant Abbott was running a messy production line in Michigan around the same time that a bacterial outbreak linked to its products killed two babies and infected others, the FDA said.
On Tuesday, FDA bosses shared an initial report that its inspectors found Abbott was not keeping surfaces and equipment clean at its Sturgis infant formula facility. It makes many of the best selling brands of infant formula in America.
An official report will follow along with a likely FDA warning. This is not the most severe type of enforcement an agency can take and is intended to give manufacturers a chance to fix the problem. But it will strengthen the position of affected families planning to sue Abbott for harming their babies.
Hygiene lapses were noted weeks before products were recalled due to suspected cronobacteria contamination, and FDA inspectors have remained at the plant ever since.
And the FDA says they found good reasons to link this outbreak to the plant after finding eight cases of Cronobacteria infection at the plant between fall 2019 and February 2022.
The FDA said Abbott’s compounding facility in Sturgis, Michigan did not maintain clean surfaces and had a history of bacterial contamination.
The disease can cause fatal infections such as meningitis.
The latest infection was linked to five hospitalizations and two infant deaths in Ohio between September 2021 and March 2022, according to the FDA.
The agency said consumers should avoid dry infant formulas from Similac, Alimentum and EleCare, which were made in a dirty facility.
Abbott, which also recalled its Similac PM 60/40 product, said in a statement that it “takes this very seriously and is working closely with the FDA to implement corrective actions.”
The company did not say how many of their products were recalled, but brands like Similac are among the best-selling formulas in the US and internationally.
Cronobacter bacteria were found at the facility during a period when five infants were hospitalized and two died after drinking formula. Two-month-old Da’Veon Jones (pictured) from Las Vegas was the last to fall ill last month.
Da’Veon fell ill after being given the Abbott formula and is now recovering from his injuries.
The FDA has said consumers should avoid Similac, Alimentum and EleCare powdered infant formula, which were made in a dirty facility.
How to check if your baby’s formula has been harmed
The FDA has stated that buyers should avoid Similac, Alimentum, and EleCare formulas if they meet all of the following criteria:
- The first two digits of the code are from 22 to 37; as well as
- The code on the container contains K8, SH or Z2; as well as
- Expiry date: 04/01/2022 (April 2022) or later.
Recalled products can be identified by examining the number on the bottom of each container.
Parents can also enter the code on the bottom of the package at similacrecall.com to see if their product is affected, or call 800-986-8540.
Parents can identify recalled products by the number on the bottom of each container.
The FDA did not say why investigators did not arrive at the plant earlier, despite the cases starting in September last year and the recall of products not shipped until last month.
The FDA did not immediately respond to ‘s request for comment.
Sarah Sorscher of the Center for Science in the Public Interest told Fox that parents need more answers about how the outbreak happened.
“This sheds a little more light on what went wrong, but we still don’t have all the answers,” Sorscher said.
“Abbott and the FDA really need to do more work to get to the bottom of what happened so we can prevent the next outbreak.”
Tuesday’s news is the latest to come out of the recall after US Senators Patty Murray of Washington and Bob Casey of Pennsylvania demanded the company turn over documents relating to its plant and pollution last month.
At least half a dozen parents filed lawsuits in U.S. District Court in Illinois and Florida in February in March alleging that the company used “unfair and misleading practices and practices designed to mislead the public in connection with their promotion, marketing, advertising, packaging, labelling. , distribution and / or sale of IT products.
David Silverman, an attorney for two Miami parents whose child fell ill after drinking Abbott’s product, said families are demanding accountability for the company’s alleged unsafe practices.
“It is clear that higher safety standards are needed at Abbott’s manufacturing facility,” Silverman said in a statement.
“Families expect their infant formula to be safe to consume and free from bacteria and toxic impurities. They should be able to use these products knowing they are safe.”
According to the FDA, Cronobacter sakazakii bacteria can cause life-threatening infections or meningitis, symptoms of which can include poor nutrition, irritability, temperature changes, yellowing of the skin or eyes, wheezing, and abnormal movements.
The first symptoms in infants under 1 year of age are usually fever accompanied by poor feeding, excessive crying, or very low energy.
It can also cause damage to the intestines and spread to other parts of the body, which can lead to swelling of the membranes surrounding the brain and spinal cord.
Some babies may also have seizures.
The bacteria Cronobacter sakazakii (pictured) can cause life-threatening infections or meningitis.
Harm Cronobacter sakazakii
Cronobacter sakazakii is a bacterium that can cause life-threatening infections or meningitis.
The first symptoms in infants are usually fever accompanied by poor nutrition, excessive crying, or very low energy.
It can also cause damage to the intestines and spread to other parts of the body, which can lead to swelling of the membranes surrounding the brain and spinal cord, or meningitis.
If it spreads into the blood, it can also cause jaundice or yellowing of the skin or eyes.
Two-month-old Da’Veon Jones of Las Vegas was the last to get sick from the product after he was admitted to the hospital on Feb. 21, where he was treated for severe dehydration, a rash and bowel problems.
“I just checked his temperature and it’s 104, and then he’s moaning and groaning and he’s red like a red pepper,” Dah’Veon’s grandmother, Mellon Co., told 8NewsNow.
Children two months of age and younger are more likely to develop much more serious complications.
Abbott announced the product recall on February 17, and Joe Manning, executive vice president of nutrition, said in a statement: “We know parents depend on us to provide the highest quality formulas.
“We are taking this action to let parents know they can try us out so that we meet our high standards as well as theirs.
“We deeply regret the concern and inconvenience this situation will cause to parents, guardians and healthcare professionals.”
Consumers are being asked to enter a code on the bottom of their package to confirm if it is part of a recall, and those using the formula are being asked to switch brands.
Liquid infant formula is not subject to a recall.
Anyone whose child is experiencing any symptoms of an infection is also advised to call their primary care physician immediately.