From the CDC..."Cronobacter multi-species complex (formerly Enterobacter sakazakii) is a group of gram-negative bacteria that exists in the environment and which can survive in very dry conditions. The natural habitat for Cronobacter is not known. It has been found in a variety of dry foods, including powdered infant formula, skimmed milk powder, herbal teas, and starches. It has also been found in wastewater. Cronobacter illnesses are rare [2 to 4 cases per year], but they are frequently lethal for infants and can be serious among people with immunocompromising conditions and the elderly."
Cronobacter can cause diarrhea and urinary tract infections in people of all ages, but infection can be very serious in infants (<12 months), especially during the first few weeks after birth. Although cases are rare, the organism can cause a dangerous blood infection (sepsis) or make the linings surrounding the brain and spinal cord swell (meningitis).
"Cronobacter infections have been associated with consumption of reconstituted powdered infant formula. In several outbreak investigations, Cronobacter has been found in powdered infant formula that had been contaminated in the factory. In other cases, Cronobacter might have contaminated the powdered infant formula after it was opened at home or elsewhere. Powdered infant formula is not sterile. Manufacturers report that, using current methods, it is not possible to produce sterile powdered infant formula. At the factory, Cronobacter could get into formula powder if contaminated raw materials are used to make the formula, or if the formula powder touches a contaminated surface in the manufacturing environment."
https://www.fda.gov/food/outbreaks-foodborne-illness/fda-investigation-cronobacter-and-salmonella-complaints-powdered-infant-formula-february-2022
FDA Investigation of Cronobacter and Salmonella Complaints: Powdered Infant Formula (February 2022)
Do not use recalled Similac, Alimentum, or EleCare powdered infant formula
02/18/2022
The FDA, along with CDC and state and local partners are investigating four consumer complaints of infant illness related to products from Abbott Nutrition’s Sturgis, MI facility received from 9/20/2021 to 1/11/2022. All of the cases are reported to have consumed powdered infant formula (IF) produced from Abbott Nutrition’s Sturgis, MI facility. These complaints include three reports of Cronobacter sakazakii infections and one report of Salmonella Newport infection in infants. All four cases related to these complaints were hospitalized and Cronobacter may have contributed to a death in one case.
FDA has initiated an onsite inspection at the facility. Findings to date include several positive Cronobacter results from environmental samples taken by FDA, and adverse inspectional observations by FDA investigators. A review of the firm’s internal records also indicate environmental contamination with Cronobacter sakazakii and the firm’s destruction of product due to the presence of Cronobacter.
FDA is issuing this advisory to alert consumers to avoid purchasing or using recalled powdered infant formula produced in the Sturgis, MI facility.
On 2/17/2022, Abbott Nutrition initiated a voluntary recall of certain powdered infant formulas. Products made at the Sturgis facility can be found across the United States and were likely exported to other countries as well. Canadian health officials have also issued a recall warningExternal Link Disclaimer. FDA is continuing to investigate and will update this advisory should additional consumer safety information become available.
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.
Additional recall information 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:
The recall does not include liquid formula products or any metabolic deficiency nutrition formulas. Consumers should continue to use all product not included in the recall.
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.
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 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.
Abbott Voluntarily Recalls Powder Formulas Manufactured at One Plant
Summary
Company Announcement Date: February 17, 2022
FDA Publish Date: February 17, 2022
Product Type: Food & Beverages
Reason for Announcement: Consumer complaints regarding Cronobacter sakazakii, Salmonella Newport.
Company Name: Abbott
Brand Name: Similac, Alimentum, and EleCare
Product Description: Powder Infant Formula
Company Announcement
Abbott (NYSE: ABT) is initiating a proactive, voluntary recall of powder formulas, including Similac, Alimentum and EleCare manufactured in Sturgis, Mich., one of the company's manufacturing facilities. The recall does not include any metabolic deficiency nutrition formulas.
Abbott is voluntarily recalling these products after four consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants who had consumed powder infant formula manufactured in this facility.
Additionally, as part of Abbott's quality processes, we conduct routine testing for Cronobacter sakazakii and other pathogens in our manufacturing facilities. During testing in our Sturgis, Mich., facility, we found evidence of Cronobacter sakazakii in the plant in non-product contact areas. We found no evidence of Salmonella Newport. This investigation is ongoing.
Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. All finished products are tested for Cronobacter sakazakii, Salmonella Newport and other pathogens and they must test negative before any product is released. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella Newport.
While Abbott's testing of finished product detected no pathogens, we are taking action by recalling the powder formula manufactured in this facility with an expiration of April 1, 2022, or later. No Abbott liquid formulas, powder formulas, or nutrition products from other facilities are impacted by the recall.
Cronobacter sakazakii is commonly found in the environment and a variety of areas in the home. It can cause fever, poor feeding, excessive crying or low energy as well as other serious symptoms. It's important to follow the instructions for proper preparation, handling and storage of powder formulas.
"We know parents depend on us to provide them with the highest quality nutrition formulas," said Joe Manning, executive vice president, nutritional products, Abbott. "We're taking this action so parents know they can trust us to meet our high standards, as well as theirs. We deeply regret the concern and inconvenience this situation will cause parents, caregivers and health care professionals."
What Parents and Caregivers Should Do
The products under recall have a multidigit number on the bottom of the container starting with the first two digits 22 through 37, contains K8, SH, or Z2 and with an expiration date of April 1, 2022, or after.
To find out if the product you have is included in this recall, visit similacrecall.comExternal Link Disclaimer and type in the code on the bottom of the package, or call +1-800-986-8540 (U.S.) and follow the instructions provided. No action is needed for previously consumed product. If you have questions about feeding your child, contact your healthcare professional.
Some product was distributed to countries outside the U.S. A list of these products can be found at similacrecall.comExternal Link Disclaimer.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.comExternal Link Disclaimer, on LinkedIn at www.linkedin.com/company/abbott-/External Link Disclaimer, on Facebook at www.facebook.com/AbbottExternal Link Disclaimer and on Twitter @AbbottNewsExternal Link Disclaimer.
SOURCE Abbott
For frequently asked questions, please click here.
For further information: Abbott Media: Vicky Assardo, (224) 668-1505; Jonathon Hamilton, (224) 667-8646; Ellen Wichman, (224) 667-8522; Spanish-speaking media in U.S.: John Koval, (224) 668-5355; Spanish-speaking media outside the U.S.: Jorge Solorzano, +52 55-3333-7604; Abbott Financial: Laura Dauer, (224) 667-2299
FDA is issuing this advisory to alert consumers to avoid purchasing or using recalled powdered infant formula produced in the Sturgis, MI facility.
On 2/17/2022, Abbott Nutrition initiated a voluntary recall of certain powdered infant formulas. Products made at the Sturgis facility can be found across the United States and were likely exported to other countries as well. Canadian health officials have also issued a recall warningExternal Link Disclaimer. FDA is continuing to investigate and will update this advisory should additional consumer safety information become available.
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.
Additional recall information 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:
The recall does not include liquid formula products or any metabolic deficiency nutrition formulas. Consumers should continue to use all product not included in the recall.
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.
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 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.
Abbott Voluntarily Recalls Powder Formulas Manufactured at One Plant
Summary
Company Announcement Date: February 17, 2022
FDA Publish Date: February 17, 2022
Product Type: Food & Beverages
Reason for Announcement: Consumer complaints regarding Cronobacter sakazakii, Salmonella Newport.
Company Name: Abbott
Brand Name: Similac, Alimentum, and EleCare
Product Description: Powder Infant Formula
Company Announcement
Abbott (NYSE: ABT) is initiating a proactive, voluntary recall of powder formulas, including Similac, Alimentum and EleCare manufactured in Sturgis, Mich., one of the company's manufacturing facilities. The recall does not include any metabolic deficiency nutrition formulas.
Abbott is voluntarily recalling these products after four consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants who had consumed powder infant formula manufactured in this facility.
Additionally, as part of Abbott's quality processes, we conduct routine testing for Cronobacter sakazakii and other pathogens in our manufacturing facilities. During testing in our Sturgis, Mich., facility, we found evidence of Cronobacter sakazakii in the plant in non-product contact areas. We found no evidence of Salmonella Newport. This investigation is ongoing.
Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. All finished products are tested for Cronobacter sakazakii, Salmonella Newport and other pathogens and they must test negative before any product is released. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella Newport.
While Abbott's testing of finished product detected no pathogens, we are taking action by recalling the powder formula manufactured in this facility with an expiration of April 1, 2022, or later. No Abbott liquid formulas, powder formulas, or nutrition products from other facilities are impacted by the recall.
Cronobacter sakazakii is commonly found in the environment and a variety of areas in the home. It can cause fever, poor feeding, excessive crying or low energy as well as other serious symptoms. It's important to follow the instructions for proper preparation, handling and storage of powder formulas.
"We know parents depend on us to provide them with the highest quality nutrition formulas," said Joe Manning, executive vice president, nutritional products, Abbott. "We're taking this action so parents know they can trust us to meet our high standards, as well as theirs. We deeply regret the concern and inconvenience this situation will cause parents, caregivers and health care professionals."
What Parents and Caregivers Should Do
The products under recall have a multidigit number on the bottom of the container starting with the first two digits 22 through 37, contains K8, SH, or Z2 and with an expiration date of April 1, 2022, or after.
To find out if the product you have is included in this recall, visit similacrecall.comExternal Link Disclaimer and type in the code on the bottom of the package, or call +1-800-986-8540 (U.S.) and follow the instructions provided. No action is needed for previously consumed product. If you have questions about feeding your child, contact your healthcare professional.
Some product was distributed to countries outside the U.S. A list of these products can be found at similacrecall.comExternal Link Disclaimer.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.comExternal Link Disclaimer, on LinkedIn at www.linkedin.com/company/abbott-/External Link Disclaimer, on Facebook at www.facebook.com/AbbottExternal Link Disclaimer and on Twitter @AbbottNewsExternal Link Disclaimer.
SOURCE Abbott
For frequently asked questions, please click here.
For further information: Abbott Media: Vicky Assardo, (224) 668-1505; Jonathon Hamilton, (224) 667-8646; Ellen Wichman, (224) 667-8522; Spanish-speaking media in U.S.: John Koval, (224) 668-5355; Spanish-speaking media outside the U.S.: Jorge Solorzano, +52 55-3333-7604; Abbott Financial: Laura Dauer, (224) 667-2299
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