Category Archives: cross contamination

USA – FDA Investigating Another Infant Death Potentially Related to Abbott Baby Formula

Food Safety Tech

On Wednesday, June 22, the FDA announced that it was investigating the death of an infant that occurred in January 2022 and is potentially related to Abbott baby formula. In a statement, the FDA said that it was notified of the death through a consumer complaint received on June 10, 2022. “The agency has initiated an investigation, given that the complaint referenced that the infant had consumed an Abbott product. However, the investigation of this most recent consumer complaint is in its preliminary stages and the agency will provide an update as it learns more,” the statement read.

The FDA has previously reported its review of complaints related to nine infant deaths. Two were found to be associated with the Abbott Nutrition Sturgis plant investigation. However, the FDA notes that, despite extensive investigation, the evidence does not rule in or rule out a definitive link between these infant deaths and the product produced at Abbott Nutrition’s Sturgis, Michigan-based plant.

Canada – Certain Abbott brand powdered infant formula products recalled due to possible Cronobacter sakazakii and Salmonella

CFIA

Summary

Product
Certain powdered infant formula products
Issue
Food – Microbial Contamination – Salmonella
Food – Microbial Contamination – Other
What to do

Do not consume, use, sell, serve, or distribute the recalled products

Affected products

Issue

Shoppers Drug Mart is recalling certain Abbott brand powdered infant formula products from the marketplace due to possible Cronobacter sakazakii and Salmonella contamination. The products were previously recalled on February 17, 2022 and some units were sold via on-line in error.

What you should do

  • If you think you became sick from consuming a recalled product, call your doctor
  • Check to see if you have the recalled products in your home or establishment
  • Do not consume the recalled products
  • Recalled products should be thrown out or returned to the location where they were purchased

Food contaminated with Cronobacter sakazakii may not look or smell spoiled but can still make you sick. Although Cronobacter sakazakii is not commonly linked to human illness, in rare cases it can cause serious or fatal infections. Cronobacter sakazakii can cause rare bloodstream and central nervous system infections and has been associated with severe intestinal infection (necrotizing enterocolitis) and blood poisoning (sepsis), especially in newborns.

Food contaminated with Salmonella may not look or smell spoiled but can still make you sick. Young children, pregnant women, the elderly and people with weakened immune systems may contract serious and sometimes deadly infections. Healthy people may experience short-term symptoms such as fever, headache, vomiting, nausea, abdominal cramps and diarrhea. Long-term complications may include severe arthritis.

USA – CDC closes infant formula outbreak investigation; FDA continues work to find source; USDA works to resolve shortages – Cronobacter

Food Safety News

The CDC has declared that an outbreak of cronobacter infections among babies is over, but the Food and Drug Administration is continuing its investigation into the maker of the implicated infant formula.

The FDA received four complaints of cronobacter infections in infants beginning on Sept. 20, 2021, and running through Jan. 11, 2022. Two of the infected babies died. Parents of all four infants reported having fed their children formula produced by Abbott Nutrition before they became ill.

The Centers for Disease Control and Prevention worked with the FDA and state health departments to investigate the outbreak. The FDA began an investigation into Abbott’s Sturgis, MI, production facility and the plant remains closed while the investigation continues. Although five strains of cronobacter have been found in the production plant, none of them is an exact match for the patient samples.

The situation led to the recall of certain Similac products as well as products sold under the Alimentum and EleCare brands.

Research – Evaluation of the safety and efficacy of lactic acid to reduce microbiological surface contamination on carcases from kangaroos, wild pigs, goats and sheep

EFSA

Studies evaluating the safety and efficacy of lactic acid to reduce microbiological surface contamination from carcases of wild game (i.e. kangaroos and wild pigs) and small stock (i.e. goats and sheep) before chilling at the slaughterhouse were assessed. Wild pig and kangaroo hide‐on carcases may have been chilled before they arrive at the slaughterhouse and are treated after removal of the hides. Lactic acid solutions (2–5%) are applied to the carcases at temperatures of up to 55°C by spraying or misting. The treatment lasts 6–7 s per carcass side. The Panel concluded that: [1] the treatment is of no safety concern, provided that the lactic acid complies with the European Union specifications for food additives; [2] based on the available evidence, it was not possible to conclude on the efficacy of spraying or misting lactic acid on kangaroo, wild pig, goats and sheep carcases; [3] treatment of the above‐mentioned carcases with lactic acid may induce reduced susceptibility to the same substance, but this can be minimised; there is currently no evidence that prior exposure of food‐borne pathogens to lactic acid leads to the occurrence of resistance levels that compromise antimicrobial therapy; and [4] the release of lactic acid is not of concern for the environment, assuming that wastewaters released by the slaughterhouses are treated on‐site, if necessary, to counter the potentially low pH caused by lactic acid, in compliance with local rules.

USA – FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022)

FDA

Content current as of:
05/11/2022

If you want to check if your powdered formula is part of the recall, you can enter the product lot code on the bottom of your package on the company’s websiteExternal Link Disclaimer.

If you have questions or need information about the recall, you can Submit Questions/Get Assistance.

If your infant is experiencing symptoms related to Cronobacter infection, such as poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements; contact your health care provider to report their symptoms and receive immediate care.

To report an illness or adverse event, you can

The U.S. Food and Drug Administration (FDA), along with the Centers for Disease Control and Prevention (CDC) and state and local partners are investigating consumer complaints and/or reports, received from 9/20/2021 to 1/11/2022, of infant illness related to products from Abbott Nutrition’s Sturgis, MI, facility. The four ill patients are reported to have consumed powdered infant formula produced from Abbott Nutrition’s Sturgis, MI, facility.

On May 10, 2022, the U.S. Food and Drug Administration provided an update on its work to increase the availability of infant and specialty formula products. This update was announced with a separate press release.

Following the voluntary recall and hold of certain powdered infant formula products produced at the Abbott Nutrition facility in Sturgis, MI, Abbott has committed to completing enhanced testing of stored product batches prior to making release determinations. While the FDA recognizes that Abbott has conducted standard product testing, there were a limited number of samples tested. Additionally, although finished product testing does not eliminate the risk of contamination, the enhanced testing will provide for a greater chance to detect Cronobacter sakazakii, if present; however, this enhanced level of testing will take additional time.

In the meantime, the FDA has informed Abbott Nutrition that the agency has no objection to the company immediately releasing product to individuals needing urgent, life-sustaining supplies of the specialty and metabolic formulas listed below on a case-by-case basis. The FDA is concerned that the risk of not having certain specialty and metabolic products available could significantly worsen underlying medical conditions and in some cases pose life-threatening risks for infants and individuals who rely on these products. In these circumstances, the benefit of allowing parents, in consultation with their healthcare providers, to access these products may outweigh the potential risk of bacterial infection.

Abbott has confirmed with the FDA that the company will consider release of these products on a case-by-case basis, depending on product availability and the severity of the individual’s need. Patients and caregivers seeking access to these products should contact Abbott directly to request that a product be made available to them by calling 1-800-881-0876.

It is important for parents and caregivers to understand that any products released on a case-by-case basis at this time were made at Abbott Nutrition’s Sturgis, MI, facility, and that the processes, procedures, and conditions that the FDA observed during its inspection of the Sturgis MI production facility from January 31 – March 18, 2022, raise concerns that powdered infant formula produced at this facility prior to the FDA’s inspection carry a risk of contamination. Therefore, those seeking access should consult with their healthcare provider in considering whether the benefit of consuming such product outweighs the potential risk of bacterial infection in the user’s particular circumstances. Parents and caregivers should continue to work with their medical provider to consider whether comparable alternative products may be appropriate.

Parents and caregivers who obtain these products should carefully follow Abbott’s preparation instructions as indicated on the product container. Should product released on a case-by-case basis be used, parents and caregiver should pay close attention to the user’s health status and alert a healthcare provider immediately of any change in health status. In the meantime, the FDA is continuing to work diligently to ensure the safe resumption of production of infant formula at Abbott Nutrition’s Sturgis, Michigan facility.

Specialty and Metabolic Formulas that may be Released on a Case-By-Case Basis:

  • Glutarex-1
  • Glutarex-2
  • Cyclinex-1
  • Cyclinex-2
  • Hominex-1
  • Hominex-2
  • I-Valex-1
  • I-Valex-2
  • Ketonex-1
  • Ketonex-2
  • Phenex-1
  • Phenex-2
  • Phenex-2 Vanilla
  • Pro-Phree
  • Propimex-1
  • Propimex-2
  • ProViMin
  • Calcilo XD
  • Tyrex-1
  • Tyrex-2
  • Similac PM 60/40

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 websiteExternal Link Disclaimer to check if it is part of the recall.

Additional information for parents and caregivers of infants receiving medical specialty infant formulas and individuals using certain medical foods is available below.

Additional Information for Parents and Caregivers:

The recalls do not include liquid formula products.

Parents and caregivers should never dilute infant formula and should not make or feed homemade infant formula to infants. Consumers should also avoid purchasing imported formula through online sales, as it has the potential to be counterfeit.

If your regular formula is not available, contact your child’s healthcare provider for recommendations on changing feeding practices.

If you get infant formula through WIC, do not throw the formula out. Instead, you should take it to the store for a refund and exchange or call the company at 1-800-986-8540 to help you. WIC recipients should be able to obtain a different brand of similar formula. Call your local WIC clinic for more guidance. Also see:

More information on Cronobacter and infant formula is available on CDC’s website.

Recalled powdered infant formulas have the potential to be contaminated with Cronobacter, a bacterium that can cause severe foodborne illness primarily in infants. Cronobacter infections are rare but are especially high risk for newborn infants (see symptoms below).

Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine). Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths, and abnormal body movements. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body.

If your child is experiencing any of these symptoms, you should notify your child’s healthcare provider and seek medical care for your child immediately. Healthcare providers and health departments are encouraged to report any confirmed cases of Cronobacter sakazakii to CDC.

Research – USDA-NIFA grant awarded to Arkansas food scientist to investigate low-moisture food safety

Food Safety News

The U.S. Department of Agriculture’s National Institute of Food and Agriculture has awarded an Arkansas Agricultural Experiment Station researcher a $200,000 grant to learn more about how much moisture is required to allow bacterial survival in low-moisture foods. 

The institute recognizes the dangers of pathogens in low-moisture foods as just two months ago the FDA confirmed five different strains of Cronobacter sakazakii bacteria at an Abbott Nutrition plant in Sturgis, MI, that makes infant formula that was linked to four illnesses and two deaths.

Jennifer Acuff, the awarded researcher and assistant professor in food safety and microbiology with the University of Arkansas System Division of Agriculture, says her research will help develop foundational knowledge on how bacteria persist in low-moisture food processing environments.

“We don’t really know how much water or nutrients are required to sustain these contaminating populations, but we know they can persist in the dry environment for a long time,” Acuff said. 

According to Acuff, the goal of the grant is to develop protocols for a laboratory that simulate these persistent bacteria so that they can study how to prevent their formation or mitigate the risks once they do form in a low-moisture food processing environment.

Australia – Nutricia infant formula tests positive for Cronobacter in Australia

Food Safety News

Nutricia infant formula has been found to contain Cronobacter after testing in Australia.

A batch of KetoCal 3:1 was positive for Cronobacter spp. during testing at the border by customs officials. There have been no illnesses linked to the product, and the source of contamination is being investigated by the company.

The implicated formula is a specialist product not sold to the general public but available under prescription for children with special nutritional needs.

Affected tins are batch number 101101598 with best before July 8, 2023. For many patients there is no alternative feeding option so Nutricia has provided advice to consumers on how to make the product safe.

USA – FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022)

FDA

If you want to check if your powdered formula is part of the recall, you can enter the product lot code on the bottom of your package on the company’s websiteExternal Link Disclaimer.

If you have questions or need information about the recall, you can Submit Questions/Get Assistance.

If your infant is experiencing symptoms related to Cronobacter infection, such as poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements; contact your health care provider to report their symptoms and receive immediate care.

To report an illness or adverse event, you can

The U.S. Food and Drug Administration (FDA), along with the Centers for Disease Control and Prevention (CDC) and state and local partners are investigating consumer complaints and/or reports of infant illness, received from 9/20/2021 to 1/11/2022, related to products from Abbott Nutrition’s Sturgis, MI, facility. The four ill patients are reported to have consumed powdered infant formula produced from Abbott Nutrition’s Sturgis, MI, facility.

Following the voluntary recall and hold of certain powdered infant formula products produced at the Abbott Nutrition facility in Sturgis, MI, Abbott has committed to completing enhanced testing of stored product batches prior to making release determinations. While the FDA recognizes that Abbott has conducted standard product testing, there were a limited number of samples tested. Additionally, although finished product testing does not eliminate the risk of contamination, the enhanced testing will provide for a greater chance to detect Cronobacter sakazakii, if present; however, this enhanced level of testing will take additional time.

In the meantime, the FDA has informed Abbott Nutrition that the agency has no objection to the company immediately releasing product to individuals needing urgent, life-sustaining supplies of the specialty and metabolic formulas listed below on a case-by-case basis. The FDA is concerned that the risk of not having certain specialty and metabolic products available could significantly worsen underlying medical conditions and in some cases pose life-threatening risks for infants and individuals who rely on these products. In these circumstances, the benefit of allowing parents, in consultation with their healthcare providers, to access these products may outweigh the potential risk of bacterial infection.

Abbott has confirmed with the FDA that the company will consider release of these products on a case-by-case basis, depending on product availability and the severity of the individual’s need. Patients and caregivers seeking access to these products should contact Abbott directly to request that a product be made available to them by calling 1-800-881-0876.

It is important for parents and caregivers to understand that any products released on a case-by-case basis at this time were made at Abbott Nutrition’s Sturgis, MI, facility, and that the processes, procedures, and conditions that the FDA observed during its inspection of the Sturgis MI production facility from January 31 – March 3, 2022, raise concerns that powdered infant formula produced at this facility prior to the FDA’s inspection carry a risk of contamination. Therefore, those seeking access should consult with their healthcare provider in considering whether the benefit of consuming such product outweighs the potential risk of bacterial infection in the user’s particular circumstances. Parents and caregivers should continue to work with their medical provider to consider whether comparable alternative products may be appropriate.

Parents and caregivers who obtain these products should carefully follow Abbott’s preparation instructions as indicated on the product container. Should product released on a case-by-case basis be used, parents and caregiver should pay close attention to the user’s health status and alert a healthcare provider immediately of any change in health status. In the meantime, the FDA is continuing to work diligently to ensure the safe resumption of production of infant formula at Abbott Nutrition’s Sturgis, Michigan facility.

Specialty and Metabolic Formulas that may be Released on a Case-By-Case Basis:

  • Glutarex-1
  • Glutarex-2
  • Cyclinex-1
  • Cyclinex-2
  • Hominex-1
  • Hominex-2
  • I-Valex-1
  • I-Valex-2
  • Ketonex-1
  • Ketonex-2
  • Phenex-1
  • Phenex-2
  • Phenex-2 Vanilla
  • Pro-Phree
  • Propimex-1
  • Propimex-2
  • ProViMin
  • Calcilo XD
  • Tyrex-1
  • Tyrex-2
  • Similac PM 60/40

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 websiteExternal Link Disclaimer to check if it is part of the recall.

Additional information for parents and caregivers of infants receiving medical specialty infant formulas and individuals using certain medical foods is available below.

Additional Information for Parents and Caregivers:

The recalls do not include liquid formula products.

Parents and caregivers should never dilute infant formula and should not make or feed homemade infant formula to infants. Consumers should also avoid purchasing imported formula through online sales, as it has the potential to be counterfeit.

If your regular formula is not available, contact your child’s healthcare provider for recommendations on changing feeding practices.

If you get infant formula through WIC, do not throw the formula out. Instead, you should take it to the store for a refund and exchange or call the company at 1-800-986-8540 to help you. WIC recipients should be able to obtain a different brand of similar formula. Call your local WIC clinic for more guidance. Also see:

More information on Cronobacter and infant formula is available on CDC’s website.

Recalled powdered infant formulas have the potential to be contaminated with Cronobacter, a bacterium that can cause severe foodborne illness primarily in infants. Cronobacter infections are rare but are especially high risk for newborn infants (see symptoms below).

Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine). Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths, and abnormal body movements. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body.

If your child is experiencing any of these symptoms, you should notify your child’s healthcare provider and seek medical care for your child immediately. Healthcare providers and health departments are encouraged to report any confirmed cases of Cronobacter sakazakii to CDC.

USA – Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension 2400 mg/30 mL, Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL, and Acetaminophen 650mg/ 20.3mL, Unit Dose Cups, Due to Microbial Contamination

FDA

Summary

Company Announcement Date: 
FDA Publish Date: 
Product Type: Drugs
Reason for Announcement:
Microbial Contamination
Company Name: Plastikon Healthcare, LLC
Brand Name: Major Pharmaceuticals
Product Description: Magnesia Oral Suspension 2400 mg/30 mL, Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL, and Acetaminophen 650mg/ 20.3mL

Company Announcement

3/24/2022 – Lawrence, KS, Plastikon Healthcare, LLC is voluntarily recalling three (3) lots of Milk of Magnesia 2400 mg/30 mL Oral Suspension, one (1) lot of Acetaminophen 650mg/ 20.3mL, and six (6) lots of Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL to the hospital, clinic and patient level.  The products are being recalled due to microbial contamination and failure to properly investigate failed microbial testing.

Risk Statement: This product potentially could result in illness due to intestinal distress, such as diarrhea or abdominal pain.  Individuals with a compromised immune system have a higher probability of developing a wide-spread, potentially life-threatening infection when ingesting or otherwise orally exposed to products contaminated by micro-organisms. To date, Plastikon has not received any customer complaints related to microbial concerns or reports of adverse events related to this recall.

Product indication, lot numbers, expiration dates and NDC information are listed in the table below. The product is packaged for institutional use and is sold to clinics and hospitals nationwide in single use cups with a foil lid.  The affected lots were distributed to Major Pharmaceuticals Distribution Center (wholesaler) between 5/1/2020 and 6/28/2021, who shipped to hospitals, nursing homes, and clinics nationwide.  The products are private labeled for Major Pharmaceuticals.

Product Name Milk of Magnesia 2400 mg/30 mL Oral Suspension Magnesium Hydroxide
1200mg/Aluminum
Hydroxide
1200mg/Simethicone
120mg per 30 mL
Acetaminophen 650mg/
20.3mL
Indications for use Milk of Magnesia 2400 mg/ 30 mL is indicated for the occasional relief of constipation
(irregularity) in adults and children 12 years and older or for children under 12 as recommended by a doctor.
Magnesium Hydroxide
1200mg/Aluminum
Hydroxide
1200mg/Simethicone 120mg per 30 mL is indicated for relief of acid indigestion, heartburn, sour stomach, upset stomach due to these symptoms, pressure and bloating commonly referred to as gas.
Acetaminophen 650mg/ 20.3mL indicated for temporarily relief of minor aches and pains due to, minor pain of arthritis, muscular aches, backache, premenstrual and menstrual cramps, the common cold, headache, toothache, and temporarily reduction of fever.
Lot/exp. 20024A/Mar 2022 20025A/Mar 2022
20041A/May 2022
20042A/May 2022 20043A/May 2022
20045A/May 2022
20046A/May 2022
20047A/May 2022
21067A/Jun 2023
20040A/May 2022
NDC 0904-6846-73 0904-6838-73 0904-6820-76
Type of Packaging Carton containing 100 single dose cups (10 trays x 10 cups) Carton containing 100 single dose cups (10 trays x 10 cups) Carton containing 100 single dose cups (10 trays x 10 cups)

Plastikon Healthcare places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process.  Plastikon Healthcare has notified its direct customers via a recall letter to arrange for return of any recalled product.  Anyone with an existing inventory of the lots which are being recalled should stop use and distribution, and quarantine immediately.  Return all quarantined product to the place of purchase. For clinics, hospitals, or healthcare providers that have dispensed product to patients, please notify patients regarding the recall.

Consumers with questions regarding this recall can contact Plastikon by phone at 785-330-7109 or email address (sdixon@plastikon.com) Monday through Friday from 9 am to 4 pm CST.  Patients are advised to contact their doctor or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


Company Contact Information

Consumers:
Plastikon, Sandy Dixon
 785-330-7109
 sdixon@plastikon.com

Product Photos

Germany – * Baby food * Similac, Alimentum and EleCare from the ABBOTT brand

LMW

Alert type: Food
Date of first publication: 03/25/2022
Product name:

* Baby food * Similac, Alimentum and EleCare from the ABBOTT brand

Product images:

image.jpg

BVL

Manufacturer (distributor): Abbott Nutrition in Sturgis, Michigan Country of origin: United States of America
Reason for warning:

Possible contamination with Salmonella Newport and Cronobacter sakazakii

Packaging Unit: 400 grams
Durability: from April 01, 2022
Lot identification: The first two digits of the lot number start with 22 to 37 AND the lot numbers contain the details K8, SH or Z2.
Further information:

Reference to a public warning from the US Food and Drug Administration:

Possible contamination of US infant formula with Cronobacter sakazakii and Salmonella Newport

Status 03/24/2022

The US Food and Drug Administration (FDA) warns against the use of certain powdered infant formulas manufactured by Abbott Nutrition in Sturgis, Michigan.

On February 17, 2022, Abbott announced that it had initiated a voluntary recall of certain lots of potentially affected products. The products in question are Similac, Alimentum and EleCare powdered food, which are manufactured at the plant in Sturgis, Michigan.

The recall is related to consumer complaints about Cronobacter sakazakii and Salmonella Newport infections in the United States. In all of these cases, infant formula from the manufacturer Abbott Nutrition is said to have been consumed. All five cases related to these ailments required hospitalization. In two cases, the infection may have contributed to the deaths of the patients.

The FDA is warning against the purchase and consumption of certain infant formulas manufactured at Abbott Nutrition’s Sturgis, Michigan facility.

The products were shipped within the USA and in member states of the EU (Italy, Ireland, Croatia, Netherlands, Slovenia, Spain) and other third countries (e.g. Great Britain, India, Islamic Republic of Iran, Northern Ireland, Russian Federation, Turkey, Ukraine, United States of America ) expelled. According to current knowledge, the products mentioned were not sold in Germany.

There is a possibility that consumers could have purchased the products online via marketplaces or through short-term stays in the Member States or third countries.

The FDA advises consumers not to use Similac, Alimentum, or EleCare powdered infant formula if:

  • the first two digits of the batch number begin with 22 to 37 and
  • the details K8, SH or Z2 are included and
  • a best-before date of April 1, 2022 is specified

The manufacturer offers the possibility to check the batch number of purchased products on the following page:  https://www.similacrecall.com/us/en/product-lookup.html

For more information on the FDA’s warning, please visit the following link: https://www.fda.gov/news-events/press-announcements/fda-warns-consumers-not-use-certain-powdered-infant-formula-produced- Abbott Nutrition Facility

The manufacturer’s recall can be found at the following link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-voluntarily-recalls-powder-formulas-manufactured-one-plant

For the warning in Turkish language, please refer to the following link: https://www.titck.gov.tr/duyuru/ilac-geri-cekme-24022022101035

Information on Salmonella and Cronobacter sakazakii

Salmonella  and  Cronobacter sakazakii  can cause illness in infants when present in powdered infant formula. Although Cronobacter sakazakii and Salmonella cannot grow in powdered infant formula, they can survive for a long period of time and therefore pose a potential risk after liquid addition if the product is not heated sufficiently during preparation. Contamination of infant formula powder with Cronobacter sakazakiiand salmonella can cause serious illnesses in infants, such as diarrhea (sometimes bloody), fever, sepsis or meningitis, which can cause serious neurological and developmental problems and, in rare cases, can be fatal. Sepsis and meningitis can present with poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), and abnormal breathing and movements. Among infants, newborns (<28 days), especially preterm, low birth weight, or immunocompromised infants are most at risk of becoming infected.

(Unofficial translation of the information at: https://www.fsai.ie/news_centre/food_alerts/Similac.html )

Further information on salmonella, also in other languages, can be found here: http://www.infectionsschutz.de/erregersteckbriefe/salmonellen