President Joe Biden had previously directed various agencies to import products from companies overseas that meet US standards using military planes through Operation Fly Formula. (21). Many European formulas arent approved by the FDA, although many parents still prefer them over US brands. Between the lines: Abbott said the recall "does not include any other liquid or powder formula brands or other nutrition products produced in our Columbus facility or elsewhere within our global nutrition manufacturing network. Abbott is continuing production of Similac 2 fluid ounce/59 milliliter Ready-to-Feed liquid formula products for hospitals and healthcare providers' offices on a different production line. (1), ByHeart Whole Nutrition Infant Formula Recall, The Similac Recall & The Formula Shortage (2022), in the US, worried parents are having difficulty finding supplies for their babies. Abbott is continuing production of Similac 2 fluid ounce/59 milliliter Ready-to-Feed liquid formula products for hospitals and healthcare providers' offices on a different production line. The baby had consumed Similac PM 60/40 from this lot. According to DeLauro, the whistleblower (name withheld for security reasons) wrote a 34-page report with a long list of allegations about security lapses and unsafe practices at the plant. Retail companies like Walmart have already put a cap on how many you can buy per transaction. First European Shipment Arrives In The US, House Passes $28 Million Emergency Spending & WIC Flexibility Bills. 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. Click on the "Learn More" button to see lot numbers included in the recall or scroll down to Check Lot Number. The shipment included 132 pallets of both the Nestle Health Science Alfamino Infant and the Alfamino Junior formulas. oz/59 ml ready-to-feed products: U.S. - certain lots of Similac 360 Total Care, Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Pro-Total Comfort . The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of our Sturgis facility and has not been linked to the two available patient samples or any other known infant illness. The recalled products have been sold across the country. ). Double-check the full product name, lot code, batch number, and the expiration or use by date. But something must be done to correct this serious safety concern. The following are affected by this recall: (2). On February 18, the Canadian Food Inspection Agency (CFIA) issued a recall for certain Abbott brand Similac powdered . Nine Baby Deaths Reported During FDA Investigation, From December 1, 2021, to March 3, 2022, the FDA reportedly received a total of nine reports of formula-related baby deaths, with two among the four confirmed, infections that led to the February 2022 Similac recall. . Some of the hospitalized kids suffered malnutrition after taking homemade formula or other inappropriate substitutions. ", Dunkin' fans heated over rewards program change, Time running out to claim child tax credits, stimulus checks, Florida orange crop declines after Hurricane Ian damage, Burger King adds spicy Ghost Pepper Whopper for Halloween, "If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur.". (37), Currently, 90% of the US formula market is dominated by just four players: (37), These four companies also dominate the federal contracts for the WIC program for low-income families, which accounts for 50% of US formula productions. It may cause a decrease in vitamin C levels over time. Similac 360 Total Care Sensitive 30.2 oz. A thorough review of all available data indicates that the infant formula produced at our Sturgis facility is not likely the source of infection in the reported cases and that there was not an outbreak caused by products from the facility. RECALL NOTICE: OUTSIDE US October 2022 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 brands Similac Pro-Total Comfort , Similac 360 Total Care , Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Stage 1, Similac Water (Sterilized), Similac Neosure and . Similac infant formula will continue to be produced in alternative product sizes and formats for delivery to retail locations, in addition to increased production throughout our global manufacturing network. Before the massive Similac recall, Abbott Nutrition topped the market spot with 40% of the market share, closely followed by the long-time number 2 player in the US, Enfamil. Why did it take four months to pull this formula off store shelves? This recall does not include any other liquid or powder formula brands or other nutrition products produced in our Columbus facility or elsewhere within our global nutrition manufacturing network. (21), The first two Defense Production Act authorizations are priority orders for Reckitt Benckiser (Mead-Johnsons Enfamil) and Abbott Nutrition: (31), Once the Abbott plant resumes operations, these priority shipments are expected to help increase their production by one-third. (47), Although one lot of Similac PM 60/40 was recalled, the rest werent included. For many of these kids, finding the right formula can be a long, complicated process to make sure that it can meet their nutritional needs while also ensuring it wont trigger a potentially dangerous reaction, including dehydration or diarrhea. You can check if your powdered formula is affected by inspecting the code printed near the expiration date. This recall equates to less than one day's worth of the total number of ounces of infant formula fed in the U.S. and is not expected to impact the overall U.S. infant formula supply. You can find more information about these recalls below. Similac 360 Total Care Sensitive Milk-based infant formula with iron A 20 Cal/fl oz, nutritionally complete, non-GMO, milk-based, iron fortified infant formula designed for use for sensitive tummies as a milk-based alternative to standard milk-based formulas for sensitive tummies. But they had to be hospitalized so they could be fed. (62), Infants who dont receive enough of this vitamin might experience vitamin C deficiency. After dismissal, the employee reportedly made the false allegations and submitted the false report to multiple authorities. Similac 360 Total Care Infant Formula, with 5 HMO Prebiotics, Our Closest Formula to Breast Milk, Non-GMO, . (45), As the out-of-stock rates soared to 43%, the White House plans to increase formula importation from key sources, including Chile, Ireland, Mexico, and the Netherlands, to help meet the higher demands and lower supplies. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. Safety Alerts, Ready-to-feed liquid products for infants and children, An official website of the United States government, : (41), Jennifer Crouse, the Clinical Nutrition Manager of Childrens Wisconsin, disclosed that several children have also been admitted to their hospital or treated at the ER. This can result in spoilage. (29), Califf insisted that theres a need for major improvements at the FDA, not because people were bad but because they needed the right resources and consistent leadership. We are voluntarily initiating this recall because a small percentage of bottles in the recalled lots have bottle caps that may not have sealed completely, which could result in product spoilage. If yes, what happened, and which products were included? Abbott is initiating a proactive, voluntary recall of certain lots of 2 fluid ounce/59 milliliter bottles of Ready-to-Feed liquid products for infants and children, including the brands. A review of the firms internal records also indicate environmental contamination with Cronobacter sakazakii and the firms destruction of product due to the presence of Cronobacter. (1), These products were distributed to some doctors offices, hospitals, distributors, and retailers in the US, Canada, Puerto Rico, Trinidad & Tobago, Curacao, Barbados, St Thomas, Jamaica, St Croix, Dominican Republic, Panama, Colombia, and Haiti. Similac 360 Total Care Sensitive . According to Dr. Corkins, the preschooler has been admitted since April and remains at the hospital, while the toddler was only hospitalized for about a week. (2)(3). Those infected with salmonella might experience fever, diarrhea and abdominal cramps. It also does not include any amino acid-based formulas or metabolic nutrition formulas. Aside from these two children, at least three babies have been hospitalized at the Medical University of South Carolina Shawn Jenkins Childrens Hospital in Charleston, South Carolina, due to intolerance after their parents or caregivers tried other formulas due to the shortage. (37). (26), Since Abbott has over 40% share of the US infant formula market, their formula recall and subsequent plant shutdown badly affected the formula supply. The CDC (Centers for Disease Control and Prevention) announced on May 12, 2022, that it had closed the Abbott Nutrition investigation that linked the formula manufacturer to deadly Cronobacter infections. The action comes after learning of the death of an infant who tested positive forCronobacter sakazakiiand who we were informed had consumed Similac PM 60/40 from this lot. Heres Everything You Need To Know, Nutricia Formula Wasnt Recalled in 2022, However It Did Test Positive For Cronobacter. We want to extend our heartfelt sympathies to the family. The FDA issued the recall advisory after four infants from three different states (MN, OH, and TX) fell ill after reportedly consuming Similac powdered infant formula produced in Abbott Nutritions Sturgis, Michigan facility. (30), Although she called the shortage unconscionable and tragic, Pelosi didnt specify the details of the possible indictment. However, she clarified that her remarks about the need for criminal charges arent associated with any of her colleagues. (30), To directly address the formula shortage, Biden invoked the Defense Production Act on May 18, 2022. According to the hospital spokesperson, the kids ranged from babies to older children. (1)(2), Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. Additionally, retained samples related to the three complaints forCronobacter sakazakiitested negative forCronobacter. According to the recall advisory, products from Abbott Nutritions Sturgis, Michigan facility have been distributed across the US and likely to have been exported to other countries. Update password per the new system standards (8 Characters). Abbott clarifies that no distributed product (Similac PM 60/40 or the previously recalled Similac, Alimentum, and EleCare powdered infant formulas) tested positive for the presence of Cronobacter sakazakii. Now you can switch to digital savings by phone on your favorite formulasheres how: Thanks, but I'll stick with paper for now. These specialty formulas were prioritized because theyre in short supply in the US and serve a critical medical purpose for children with cows milk protein allergies. Bing Guan/Reuters (16), 44,000 pounds (equivalent to approximately 548,000 eight-ounce bottles) of specialty infant formulas Nestl Health Science Alfamino and Alfamino Junior arrived at the Louisville International Airport from Switzerland. Password reset email has been sent. (6), In response, deputy commissioner Frank Yiannas of the FDAs Office of Food Policy and Response submitted his resignation, effective February 24. (7), When Abbott shut down from February to June 2022, it worsened the already existing formula shortage. As of May 8, 2022, market research company Datasembly estimates that 43% of the top-selling formula brands are out of stock. The company clarified that these products are only available in limited quantities because production hasnt resumed at the Sturgis facility. The case remains under investigation, with authorities still trying to determine the cause of the infants, Abbott clarifies that no distributed product (Similac PM 60/40 or the previously recalled Similac, Alimentum, and EleCare powdered infant formulas) tested positive for the presence of, Tests of retained product samples from the recalled Similac PM 60/40 lot were negative for, Similac Recall February 2022 (First Recall), Similac recalls several powdered formulas for possible contamination that can cause, infection. Recalled: Similac Formulas Manufacturer's Recall Notice FDA Recall Notice sold at: Target Stores and Target.com recall date: 2/17/2022 Recall Description For more specific information regarding this recall, visit the government agency or manufacturer website: Product Recall Details Target Item Number: (9), The FDA plans on allowing the import of overseas formulas from temporary importers to go beyond the shortage in a bid to prevent it from happening again. (46), Retailers like Target, CVS, and Walmart have since put a cap on the number of formula packs that consumers can buy online and from their stores. Many parents are closely monitoring infant formula and. (31), Through the Operation Fly Formula, the first batch of formulas (78,000 lbs) arrived in the US to supply specialty infant formula. Abbott voluntarily recalled one lot of Similac PM 60/40 with lot #27032K80 (can) or lot # 27032K800 (case) also manufactured in the companys facility in Sturgis, Michigan. The recall was issued following consumer reports of four babies hospitalized, and one possible death due to, Similac, Alimentum, and EleCare powdered infant formulas, The code at the bottom of the package or container contains K8, SH, or Z2, The first two digits of the code are numbers from 22 to 37, The expiration date code is 4-1-2022 (APR 2022) or later. Overview Searching for a milk formula for your little one, but unsure which one to pick? Photo: Stefani Reynolds / AFP via Getty Images. A thorough review of all available data indicates that the infant formula produced at our Sturgis facility is not likely the source of infection in the reported cases and that there was not an outbreak caused by products from the facility., Findings released by federal safety inspectors on March 22, 2022, show that Abbotts Sturgis, Michigan manufacturing plant involved in the recent Similac recall had several safety issues. (28), Then, the company allegedly increased its dividends by over 25% and offered shareholders a stock buyback program worth $5 billion. Previous investigations by the FDA (Food and Drug Administration) reportedly discovered several violations, including Abbotts lax safety protocols and bacterial contamination at its manufacturing facility. Failure to establish a system of process controls that covers all stages of processing to ensure that baby formula doesnt become contaminated due to the presence of microorganisms (e.g., bacteria) in the formula or in its processing environment. Enfamil NeuroPro Sensitive 19.5 oz . Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. The Alfamino Junior formulas but unsure which one to pick on may 18, the kids from. New system standards ( 8 Characters ) market research company Datasembly estimates that 43 similac 360 total care recalled. 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