FDA: Abbott Infant Formula: Did not have controls in place to prevent Cronobacter contamination

The result – 4 sick with 2 dead.

The FDA, along with CDC and state and local partners are investigating consumer complaints and/or reports of infant illness related to products from Abbott Nutrition’s Sturgis, MI facility. All of the ill patients are reported to have consumed powdered infant formula produced from Abbott Nutrition’s Sturgis, MI facility.

The FDA is releasing the FDA Form 483s from three inspections conducted at Abbott Nutrition’s facility on Sept. 16-24, 2019, Sept. 20-24, 2021, and Jan. 31-March 18, 2022. The inspectional observations in these Form 483s do not constitute final FDA determinations of whether any condition was or is in violation of the Federal Food, Drug, and Cosmetic Act or any of its implementing regulations. FDA will take appropriate action in the future – if warranted – as we continue to evaluate the 2022 inspectional findings.

Important observations noted in the 2022 Form 483 include, but are not limited to:

• [Abbott Nutrition] did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment.
• [Abbott Nutrition] did not ensure that all surfaces that contacted infant formula were maintained to protect infant formula from being contaminated by any source.

Once the immediate public health risk is minimized, FDA will conduct a programmatic review to ensure the maximum effectiveness of agency programs and policies related to infant formula and special medical food complaints, illnesses, and recalls.

Conducting this review is a top priority for the FDA and will be done as efficiently as possible, and we can ensure this effort will not interfere with the immediate recall response activities. We will and must continue focusing on taking all steps possible to protect the health of those who rely on safe powdered infant formula.

Recommendation

The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. Recalled products can be identified by the 7 to 9 digit code and expiration date on the bottom of the package (see image below). Products are included in the recall if they have all three items below:

• 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.

In addition to products described above, Abbott Nutrition has recalled Similac PM 60/40 with a lot code 27032K80 (can) / 27032K800 (case). At this time, Similac PM 60/40 with lot code 27032K80 (can) / 27032K800 (case) is the only type and lot of this specialty formula being recalled. Additional recall information for the initial recall is available on the FDA website. Parents can also enter their product lot code on the company’s website to check if it is part of the recall.

Use-by date is 4-1-2022 (APR 2022) or later

What do you need to know about Cronobacter sakazakii?

Cronobacter sakazakii is a bacterium that causes a rare but often fatal infection of the bloodstream and central nervous system. Infants with weakened immune systems, particularly premature infants, are most likely to contract an Cronobacter infection, although the bacteria have caused illnesses in all age groups.

Cronobacter sakazakii in Infant Formula

Most cases of Cronobacter sakazakii come from powdered infant formula contaminated with the bacterium. However, this type of infection is still very rare. High temperatures reached in preparing the formula usually kill the bacteria, but they are known to survive even after preparation.

Powdered infant formula is most likely contaminated after production, since the pasteurization process is normally adequate to kill Cronobacter sakazakii bacteria. However, if the powder is produced using the dry blending process, and not heated, Cronobacter bacteria can survive in the formula.

Symptoms of Cronobacter Infection

Cronobacter symptoms usually include the following in infants:

• Poor feeding response
• Irritability
• Jaundice
• Grunting while breathing
• Unstable body temperature

A Cronobacter sakazakii infection can also turn into meningitis, an inflammation of the membranes surrounding the brain and spinal cord. Signs of meningitis in newborns include:

• High fever
• Constant crying
• Excessive sleepiness or irritability
• Sluggishness
• Poor feeding
• A bulge in the soft spot on the top of the head
• Stiffness of the body and neck
• Seizures

Around 50 percent of infants who have Cronobacter sakazakii die, and those who survive may experience neurological impairment.

Treatment for Cronobacter sakazakii

A Cronobacter sakazakii infection is usually treatable with antibiotics, although some antibiotic-resistant strains have recently been discovered. If a newborn exhibits any of the above symptoms, consult a doctor to see whether the infant might need treatment.

How to Prevent a Cronobacter sakazakii Infection

The CDC recommends the following steps for preventing a Cronobacterinfection:

Breastfeed your infant. Breastfeeding is one of the best things you can do for your baby’s health and development. Among its benefits: preventing different kinds of infections, such as ear and respiratory infections. Very few cases of Cronobacter infections have been reported among infants fed only breast milk.

Clean, sanitize, and store feeding items and breast pump parts safely. You can help prevent contamination with germs and keep the milk you feed your baby safe by carefully cleaning, sanitizing, and storing:

• Baby bottles

• Other feeding items

• Breast pump parts

Consider using liquid formula when possible. If your baby gets formula, consider using formula sold as a liquid rather than a powder. This is especially important when your baby is less than 3 months old or if your baby was born prematurely or has a weakened immune system. Liquid infant formula is made to be sterile (without germs) and should not transmit Cronobacter infection when handled carefully. Powered formula is not sterile.

Infant formula does not need to be warmed before feeding, but some people like to warm their baby’s bottle. If you do decide to warm the bottle, never use a microwave. Microwaves heat milk and food unevenly, resulting in “hot spots” that can burn your baby’s mouth and throat.

To warm a bottle, place the bottle under warm running water, taking care to keep the water from getting into the bottle or on the nipple. Put a couple drops of infant formula on the inside of your wrist to make sure it is not too hot.

Prepare and store powdered infant formula safely. Make sure that your formula is not expired or recalled, and that the container is in good condition. Keep powdered formula lids and scoops clean, and close containers of formula as soon as possible. In most cases, it is safe to mix powdered infant formula following manufacturer’s instructions. But if your baby is less than 3 months old, was born prematurely, or has a weakened immune system, you may want to take the following extra steps to prepare your formula with hot water (at least 158°F/70°C) to protect against Cronobacter:

• Clean work surfaces, such as countertops and sinks.

• Boil water and let it cool for about 5 minutes.

• Pour into a clean bottle or feeding cup.

• Add the exact amount of formula listed on the container, and carefully shake the capped bottle rather than stirring the mixture.

• To use right away, cool the formula to body temperature to ensure it is not too hot before feeding your baby. Run the prepared, capped bottle under cool water or place it into an ice bath. Do not let the cooling water get into the bottle or on the nipple.

• Before feeding the baby, test the formula’s temperature by putting a few drops on the inside of your wrist. It should feel warm, not hot.

Use prepared infant formula within 1 hour from start of feeding and within 2 hours of preparing it. If your baby does not finish the entire bottle of formula, throw away leftover formula.

If you do not plan to use the prepared formula right away, refrigerate it immediately. Use refrigerated formula within 24 hours. If you can’t remember how long you have kept formula in the refrigerator, it is safer to throw it out than to feed it to your baby.

Keep hands clean! Always wash your hands carefully with soap and water during key times:

• Before preparing and feeding bottles or foods to your baby.

• Before touching your baby’s mouth.

• Before touching pacifiers or other things that go into your baby’s mouth.

• After using the toilet or changing diapers.

If soap and water are not available, use an alcohol-based hand sanitizer with at least 60% alcohol (check the product label to be sure). Hand sanitizer with at least 60% alcohol kills Cronobacter germs, but wash with soap and water as soon as possible after using hand sanitizer. That’s because hand sanitizer does not kill all types of germs, and it may not work as well if hands are visibly greasy or dirty. It’s also important to keep all objects clean that may enter the baby’s mouth (such as pacifiers and teethers).

Outside References

Centers for Disease Control and Prevention. “Cronobacter Infection and Infants”. CDC: Cronobacter: People at Risk. 28 February 2022. .

Black, Elaine, Ph.D Microbiology. “Managing the Risks of Cronobacter Sakazakii.” Ecolab. 3 Dec. 2014. .

Mayo Clinic. “Diseases &Conditions: Meningitis/Symptoms-Causes.” Mayoclinic.org. 2 March 2022. .

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.