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The recall impacts Alimentum, EleCare, and Human Milk Fortifier for markets outside the U.S. No other Abbott Nutrition products distributed outside of the U.S. are affected by this recall. Throughout the pandemic, FDA has also been monitoring potential supply chain risks for this category of products and has been reaching out to infant formula manufacturers and their trade groups. Check a multidigit number on the bottom of the container toknow if your product is included: More information is available at Similacrecall.com where you can type in the code on the bottom of the package. Bottom line: It's unlikely that your baby will get sick, even if you have been using one of the recalled formulas. Should product released on a case-by-case basis be used, parents and caregiver should pay close attention to the users health status and alert a healthcare provider immediately of any change in health status. This lot was distributed to the US and Israel. You can click here to see if your product is included in the recall. The products included in the recall have a multidigit number on the bottom of the container (see bottom of can, plastic jar, or pouch for this multidigit number) 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. STAY ON TOP OF RECALLS:Food safety: How to prevent food poisoning by monitoring recalls, CAR RECALLS:Does my car have a recall? Abbott EleCare Jr Amino Acid-Based Nutrition Powder Banana The expiration date is 4-1-2022 (APR 2022) or later. This is in addition to lots ofSimilac, Alimentum, and EleCare powder formula that were voluntarily recalled on Feb. 17. FDA is issuing this advisory to alert consumers to avoid purchasing or using certain powdered infant formula produced in the Sturgis, MI facility. We want to extend our heartfelt sympathies to the family. Do not use recalled infant formula. The CDC announced another illness of Cronobacter sakazakii on Feb. 28, saying it "may have been a contributing cause of death for this patient.". Abbott Similac EleCare We are also working with Abbott Nutrition on safe resumption of production at the Sturgis, MI facility. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis, prior to release. 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 Nutritions 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 FDAs inspection carry a risk of contamination. FOOD RECALLS:How technology could alert you before you eat that tainted salad, DEODORANT RECALL 2022:Brut, Sure aerosol deodorant and antiperspirant sprays recalled for benzene risk. Bing Guan/Reuters This action comes after learning of the death of an infant who tested positive for Cronobacter sakazakiiand who we were informed had consumed Similac PM 60/40 from this lot. Those infected with salmonella might experience fever, diarrhea and abdominal cramps. So all three need to be present is how I'm reading this. The FDA is working with Abbott Nutrition to better assess the impacts of the recall and understand production capacity at other Abbott facilities that produce some of the impacted brands. As of February 28, CDC has announced one additional illness of Cronobacter sakazakii with exposure to powdered infant formula produced at Abbott Nutritions Sturgis, MI facility. If your formula is impacted by the recall, you should throw it away. But if your baby is experiencing any of these symptoms, you should contact your health care provider immediately. You can also call Similac customer service at 1-800-986-8540. On May 16, 2022, the U.S. District Court for the Western District of Michigan entered a consent decree of permanent injunction between FDA and Abbott Nutrition, as well as three Abbott principals. 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. Alternate formulas are no longer available on WIC. The website you have requested also may not be optimized for your specific screen size. It is important to note that these specialty infant formulas and medical foods are not sold in traditional retail stores. Please click hereand enter the lot number (on the bottom of can, plastic jar, or pouch) in the lot locator to determine if your product is included in the recall. Similac Sensitive Powder At this time, CDC has completed laboratory testing for two clinical samples received related to this investigation. Abbott EleCare Similac Gold Click "Search". Abbott EleCare USA TODAY 0:00 1:10 Abbott Nutrition is voluntarily recalling three types of infant formula after four babies became sick with bacteria infections after consuming the products. [Abbott Nutrition] did not ensure that all surfaces that contacted infant formula were maintained to protect infant formula from being contaminated by any source. After further investigation, the FDA has determined that there is not enough information to definitively link this illness to powdered infant formula. Please call 800-986-8540 during the following operating hours to initiate the product return and refund process. According to the firm, recalled products were distributed to the following countries/locations: Australia, Bahrain, Barbados, Bermuda, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Guam, Guatemala, Hong Kong, India, Indonesia, Israel, Jordan, Kuwait, Lebanon, Malaysia, Mexico, New Zealand, Oman, Peru, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, Sudan, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam ANI South. 1. Similac PM 60/40. Phenex-1 The U.S. Food and Drug Administration issued a warning on Thursday to parents about the formulas manufactured at an Abbott plant in Michigan, identified as certain lots of Similac, Alimentum and. 02.28.2022 UPDATE: Abbott is voluntarily recalling one lot of Similac PM 60/40 (Lot #27032K80 (can) / Lot # 27032K800 (case)) manufactured in Sturgis, Michigan. If the lot number has a letter before the number, do not include it. All five (four Cronobacter infections and one Salmonella Newport infection) illnesses resulted in hospitalization and Cronobacter may have contributed to death in two patients. Home Tips, including cooking, cleaning and appliances hacks, Baby Registry Checklist: 10 Baby Products I Wish I'd Asked For. Refunds will be subject to Abbotts verification of your submission. If your product is included in the recall, immediatelydiscontinue useof the product and contact Abbott customer service at 1-800-986-8540 for further instructions. The company issued the original recall last week after receiving four complaints of babies being hospitalized with bacterial infections, one of whom died. Three of the complaints were for Cronobacter sakazakii, which can cause fever, poor feeding, excessive crying, low energy and other serious symptoms, according to the FDA. If you are not able to enter the lot number and would like to speak to a customer service representative, please call 1-800-986-8540. 2. No other Abbott nutrition products or Similac products distributed outside of the US are affected by this recall.*. The FDA will take appropriate action in the future - if warranted - as we continue to evaluate the 2022 inspectional findings. Abbott Similac Alimentum with 2'-FL HMO If you have questions about feeding your child, contact your healthcare professional. While the FDA recognizes that Abbott has conducted standard product testing, there were a limited number of samples tested. The List of Companies Receiving Enforcement Discretion for Infant Formula will be updated on a regular 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. Puerto Rico - call 787-622-5454 to contact your Abbott Consumer Relations Hotline. The recall impacts Alimentum, EleCare and Human Milk Fortifier for markets outside the US. To find out if the product you have is included in this recall, click on the button below to check your lot number. Examples of containers indicating the characters to enter in the lot search field: If you purchased or obtained your product in the United States, check the lot number with the lot locator atsimilacrecall.com. Follow USA TODAY reporter Kelly Tyko on Twitter:@KellyTyko. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis, prior to release. The first recall (Similac, Alimentum, and EleCare powdered infant formulas) was issued on February 17 due to possible contamination with Cronobacter sakazakii bacteria, which caused serious infections. All of the reported cases of illness have stemmed from powdered formula produced in Abbott Nutrition's facility in Sturgis, Michigan. This is a specialty formula for certain infants who would benefit from lowered mineral intake and was not included in the previous recall. You can also call 1-800-986-8540and follow the instructions provided. 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. There's an easy way to check if your Similac, Alimentum or EleCare formula is included in this recall. If you buy through our links, we may get a commission. Abbott EleCare Infant Formula Unflavoured On the similacrecall.com website, you can click the option "Check Lot Number" to check if . Please call Similac customer service at 800-986-8540 to discuss next steps regarding returning product and receiving a refund. The recall,. Recommendation The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. DAILY MONEY NEWSLETTER:Money tips and advice delivered right to your inbox. We recognize that the Abbott Nutrition recall resulted in consumers seeking alternative brands or types of infant formula and that the recall has created new concerns about the availability of certain types of infant formula, particularly given the overall strains on supply chains experienced during the COVID-19 pandemic. It can be found in or on household surfaces, including those used for food preparation. FDA has initiated an onsite inspection at the facility. You can read more by accessing the press release. Should product released on a case-by-case basis be used, parents and caregiver should pay close attention to the users health status and alert a healthcare provider immediately of any change in health status. Abbott Nutrition is voluntarily recalling three types of infant formula after four babies became sick with bacteria infectionsafter consuming the products. The website that you have requested also may not be optimized for your screen size. Parents and caregivers of infants receiving this specialty and metabolic formula should not reference the recall product description above, but instead should enter the product lot code found at the bottom of their package by using the Check Lot Number feature at the bottom of the companys webpage or by calling Abbott Nutrition at 1-800-881-0876. On March 18, 2022, the FDA inspection at the Abbott Nutrition facility in Sturgis, MI, was completed and a Form 483 was issued that included four observations. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. the expiration date is 4-1-2022 (APR 2022) or later, Five environmental subsamples collected from the Sturgis, MI facility were positive for, Product samples collected by FDA at the facility were analyzed for. To report an illness or adverse event, you can. Abbott Similac Alimentum Infant Formula with Iron It is therefore important to verify the product lot number on the bottom or the side of the bottle. Abbott Similac Alimentum Eye Q Plus What if I have recalled infant formula? If your retailer won't provide a refund, click here to see if your product is included in the recall. (Please see images for reference.). Call your local WIC clinic for more guidance. The recalled products were only manufactured inSturgis, Michigan, the company said. The fastest way to receive your refund is to take your product in its original container back to the retailer where you purchased the product for a refund, product exchange, or store credit, per retailer return policy. Although CORE is no longer investigating this incident, the FDA established an Incident Management Group (IMG) on April 1, 2022, to continue to work on supply chain and food safety issues. All finished infant formula powder products are tested forCronobacter,Salmonella,and other pathogens, and they must test negative before the product is released. Cronobacter sakazakii is a bacteria that in rare instances can cause illness in young infants and the elderly. The inspectional observations in this Form 483 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. In addition, the FDA has created an infographic on how to safely prepare and store powdered infant formula. Managing Editor Alison DeNisco Rayome joined CNET in 2019, and is a member of the Home team. Abbott is initiating a proactive, voluntary recall of certain lots of 2 fl oz/59 ml bottles of ready-to-feed liquid products, including the brandsSimilac Pro-Total Comfort, Similac360 Total Care, Similac360 Total CareSensitive, SimilacSpecial Care24, SimilacStage 1, SimilacWater (Sterilized), Similac NeoSure, and PedialyteElectrolyte Solution. You can also call 800-986-8540 to find out. Abbott Similac EleCare HMO Yes. Abbott Nutrition said it is cooperating with the FDA investigation into the three Cronobacter sakazakii infections and one salmonella infection, all of which required hospitalization. If it is, please call Similac customer service at 800-986-8540 to discuss next steps. These products were manufactured at the companys Columbus, Ohio, manufacturing facility and distributed primarily to hospitals, doctors offices, distributors, and some retailers in the US, including Puerto Rico; a limited number of products were sent to Canada, Colombia, the Dominican Republic, Panama, and certain countries in the Caribbean. 1. Or, if you'd rather check manually, your formula is part of the recall if all three of the following are true: 3. This includes washing your hands before preparing formula, and using prepared formula within one hour from when feeding starts. Parents and caregivers of infants and children using these products should contact their childs health care providers if they have questions about the use of these products. Similac . Importantly, no distributed product has tested positive for the presence of Cronobacter sakazakii. And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella Newport. Get editors' top picks of the day, the most interesting reviews, news stories and videos. Cronobacter infection may have contributed to the cause of death for both patients. Reported Deaths: 2* Additional recall information for the initial recall is available on the FDA website. Contact customer service in your market for more details. Abbott Similac Organic with A2 Milk Infant Formula with Iron The recall, announced Thursday, is for select lots of Similac, Alimentum and EleCare formulas that weremanufactured atan Abbott facility inSturgis, Michigan. In the form field below, enter the first 7 characters of the lot number. The recall does not include soy-based infant formula, metabolic deficiency nutrition formulas, liquid infant formula or liquid exempt infant formula. Please find the lot number on the bottom of the product container. We are committed to delivering products with the highest standards of quality, safety and performance. EleCare LCP Hypoallergenic. If your retailer wont provide a refund, click here to see if your product is included in the recall. 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. The recall does not include any metabolic deficiency nutrition formulas. Infant Formula Supply Now Available, should not make or feed homemade infant formula to infants, Expanded Abbott Nutrition Recall of Similac PM 60/40 Powdered Infant Formula, FDA Encourages Importation of Safe Infant Formula and Other Flexibilities to Further Increase Availability, Guidance for Industry on Infant Formula Enforcement Discretion Policy, List of Companies Receiving Enforcement Discretion for Infant Formula, Food Safety Tips for Retailers During an Outbreak, Helping Families Find Formula During the Infant Formula Shortage (HHS), Tips for Preparing Imported Infant Formula, Food Safety Tips for Consumers During an Outbreak, Toll-Free Numbers for WIC State Agencies (USDA), infographic on how to safely prepare and store powdered infant formula, entered a consent decree of permanent injunction between FDA and Abbott Nutrition. 2. As a result of the ongoing investigation, Abbott Nutrition has recalled certain powdered infant formula products and the FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas produced in the Sturgis, MI facility. If your product is not affected by the recall, no action is necessary and you can continue to use it. You can check if your sample product is included in the recall on the Product Lookup page, click here. Please check your spam folder for this email. By signing up, you will receive newsletters and promotional content and agree to our. Please call Similac customer service at 800-986-8540 to discuss next steps regarding returning product and receiving a refund. September 23, 2010 / 4:56 PM / CBS News. If it is, please call Similac customer service at 800-986-8540 to discuss next steps. The four ill patients are reported to have consumed powdered infant formula produced from Abbott Nutritions Sturgis, MI, facility. FDA and CDC informed the firm of these findings and on February 28, 2022, Abbott Nutrition voluntarily recalled Similac PM 60/40 powdered infant formula with the lot code 27032K800.

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