Similac powdered baby formula with an expiration date on or after April 1, 2022, and a code with first two digits of 22 through 37 and containing K8, SH or Z2 are part of a voluntary recall by its manufacturer, Abbott Nutrition. (28), This alarmed progressive economic advocacy group, Groundwork Collaborative. Find the answers below. (1). (1) Its competitor, Enfamil by Mead Johnson, may also hold around 40% of the market, while Gerber comes in third with roughly 15%. Abbott also reminds parents and caregivers that Cronobacter sakazakii can be commonly found in the environment and a variety of areas around the home. Latest News: Voluntary Recall of 2 fl oz Ready-to-Feed Liquid Products, U.S.: +1-800-986-8540, Puerto Rico: +1-787-622-5454, Barbados: 246-417-0777, Bermuda: 279-5568, Canada: 1-855-733-4201, Colombia: 1-800-518-9379, Curacao: 737-2222 Ext. Some of these facility improvements include the following: (44), US President Joe Biden met with infant formula manufacturers and retailers, including Reckitt, Gerber, Walmart, and Target, to discuss strategies to get more formula quickly yet safely onto store shelves to solve the ongoing shortage. 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. powdered infant formulas) was issued on February 17 due to possible contamination with. She encourages parents and caregivers to ask their pediatrician before giving any kind of formula substitute to their babies. Some areas of the Abbott plant were flooded and will require re-sanitization before the plant can reopen once again. . Similac 360 Total Care 32 oz Please be sure to carefully check the labels for the substitute formulas. The recall does not include any metabolic deficiency nutrition formulas. (36), A total of 192 Republican lawmakers voted against the bill, claiming that throwing millions of dollars at the problem wont fix it. (36), The Houses budget measure is expected to meet more resistance in the Senate. 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. Moms may have different reasons for choosing a particular formula for their babies. 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. 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. (51)(52), The FDAs preliminary findings show the following: (51)(52), The Senate health committee asked Abbott to detail the amount of time it took them to start the recall from the first reported case. Similac 360 Total Care Sensitive . The FDA requires formula manufacturers to meet this requirement to help prevent iron deficiency anemia, a condition that can lead to irreversible functional development outcomes. This recall was done after the death of another infant who tested positive for Cronobacter sakazakii. (7), It might have played a big role in the shortage and can be held liable, depending on the outcome of the Justice Departments investigation. Theyre now investigating the circumstances of the babys death. Crouse said that the exact number of children hospitalized relating to the formula shortage isnt available, but its apparent that theyve had several of these admissions. 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. (2), Cronobacter can cause severe, life-threatening infections such as sepsis or meningitis (inflammation of the membranes protecting the brain and spine), according to the CDC (Centers For Disease Control And Prevention). You can check if your powdered formula is affected by inspecting the code printed near the expiration date. If you have questions, please contact Abbott's Consumer Relations hotlines below in the country where you received product: More Recalls, Market However, Califf reportedly sidestepped these questions by saying that he cant share details of the agencys ongoing investigation. Why did the FDA not spring into action? (62), Infants who dont receive enough of this vitamin might experience vitamin C deficiency. Two recalled Similac products were sold between November 1, 2020, and February 17, 2022:. (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. The baby had consumed Similac PM 60/40 from this lot. But even if production starts again, Abbott explained that it could take at least 6-8 weeks before the products will be available for distribution. Oz./59 mL Bottles of Ready-to-Feed Liquid Products; Recall Is Not Expected to Impact U.S. (42). (47). 83/ounce) Enfagrow Premium Powder Toddler Formula - 32oz . (1), Affected bottle and carton or case lot numbers in the US: (1), Affected lots with the same bottle and case numbers: (1), Bottle lot numbers only (no case lot numbers provided): (1), Carton or case lot numbers only (no bottle lot numbers provided): (1). (32), The products originated from Zurich, Switzerland, and were trucked to Germany. 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. Liquid baby formula and all other products produced by Abbott Nutrition are not affected. (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. (13), The company needs to conduct comprehensive testing with an independent third party to determine if the plant is safe to reopen. Groups are calling on FDA officials to make food safety a priority to avoid a repeat of the formula crisis. Abbott Nutrition is recalling certain lots of ready-to-feed liquid baby products, including several under its Similac brand, for potential spoilage, the company said Friday. (26), He explained that none of the data matched between the specimen from the four complaints and of the retained product samples. Similac Pro-Advance Non-GMO Infant Formula with Iron, Earths Best Non-GMO Soy-Based Infant Powder Formula, Else Plant-Based Complete Nutrition for Toddlers, Baby Wipes Recall 2022: Affected Brands & Toxic Products, Similac Pro-Sensitive Vs. Similac Sensitive, Similac Pro-Sensitive Vs. 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Symptoms may include irritability with generalized tenderness. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. 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 Similac Pro-Total ComfortTM, Similac 360 Total Care, Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Stage 1, Similac NeoSure, Similac Water (Sterilized) and Pedialyte Electrolyte Solution. This can result in spoilage. This case is under investigation, and at this time the cause of the infantsCronobacter sakazakiiinfection has not been determined. Many formulas from name brands like Similac are designed to closely resemble breast milk. If a product is included in the recall, do not use the product. (49). All finished infant formula powder products are tested forCronobacter,Salmonella,and other pathogens, and they must test negative before the product is released. (39). Call your pediatrician or doctor if your child shows signs of medical issues (such as stomach upset) from drinking the recalled product. The other reports were made from Ohio and Texas in the following months. This investigation is ongoing. One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. Many parents are closely monitoring infant formula and. If yes, what happened, and which products were included? 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 . 235, 205, Dominican Republic: +1-849-200-1564, Haiti: 868-687-0223, Jamaica: 876-927-7098, Panama: 800-0410, St. Croix: 1(340) 690-7222, St. Thomas: 1(340) 690-7222, Trinidad & Tobago: 868-687-0223, Savings on Similac.com Schedule & Save purchases, Choose a preferred retailer, like Amazon or Target. After President Joe Biden announced Operation Fly Formula, several shipments have arrived from across the world to help the US solve the formula shortage. Many European formulas arent approved by the FDA, although many parents still prefer them over US brands. "We'll do whatever it takes to keep that trust and resolve this situation. In particular, this measure will let WIC participants buy any formula from any available supplier rather than be limited by the unavailable WIC-approved brand. (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. We want to extend our heartfelt sympathies to the family. Affected products have a code beginning with first two digits of 22 through 37 and containing K8, SH or Z2 and have an expiration date of April 1, 2022, or later. He admitted to reading the complaint but didnt specify when or what steps he took to immediately address the issue. Theyre doing it to fulfill the FDAs request. (1) Is Similac formula good for babies? Password reset email has been sent. Abbott Nutrition, which makes the Similac, Alimentum and EleCare brands, on Thursday issued a voluntary recall of certain formulas manufactured at its plant in Sturgis, Mich., where the formulas involved in the infections were produced. 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. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. (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. These two shipments of Bubs amounted to 380,000 lbs equivalent to approximately 4 million eight-ounce bottles. 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. It also called for the appointment of a strong leader and the reorganization of the FDAs food program. Federal inspectors found several safety violations: Some employees failed to sanitize their hands. (6), The US Justice Department, through its consumer protection branch, is reportedly conducting a criminal investigation over Abbotts possible role in the formula shortage. Enfamil NeuroPro Sensitive 19.5 oz . (47), House Appropriations Committee Chair Rep. Rosa DeLauro announced that her office received alarming documents from a whistleblower who used to work at the Abbott facility that produced the recalled Similac formulas in February. (45), The White House released the additional measures they will follow to increase the formula products available without compromising babies safety: (45), The US typically produces nearly all (around 98%) of the infant formulas it needs. (30), She further explained that its important to solve the problem as soon as possible. As of May 8, 2022, market research company Datasembly estimates that 43% of the top-selling formula brands are out of stock. 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 Similac Pro-Total Comfort TM, Similac 360 Total Care , Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Stage 1, Similac NeoSure , (33)(35), This is significant because the WIC program (Special Supplemental Nutrition Program for Women, Infants, and Children) accounts for as much as 50% of infant formula sales in the US. It isnt ideal for premature infants or those with digestive and metabolic issues. At least two kids have been hospitalized in direct connection with the formula shortage. (29), Wyden has reportedly requested Abbott for more information regarding their stock buyback program. On February 18, the Canadian Food Inspection Agency (CFIA) issued a recall for certain Abbott brand Similac powdered . (Liquid Ready-To-Drink Formula), The bottles had a missing special layer that keeps air out. But these include Similac. More are expected to arrive on three more flights in the coming weeks. (56), The Similac recall involved dozens of different lots and products. (1)(2), Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. (11), According to the FDA, the infant death reportedly happened in January. (2). (62), Lot codes 40177RH and 40172RH, with a use by date of Nov. 1, 2007, The bottles lack a special layer that keeps air out. (33), Formula makers quickly responded, with Nestle importing Alfamino from Switzerland and also Gerber Good Start Extensive HA from the Netherlands. . (1)(2), Then, ready-to-feed liquid products (product names listed below) were recalled in October over a manufacturing that might cause spoilage. The FDA clarifies that the recall is still in effect even though the investigation is closed. Why did it take four months to pull this formula off store shelves? (32), Another one was hospitalized due to mineral imbalances after their caregiver mixed their own formula. Meanwhile, Abbott said the 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.". 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. These products are being recalled because a small percentage of bottles (less than 1%) in the recalled lots have bottle caps that may not have sealed completely, which could result in spoilage. (53), Possible health risks due to incorrect labels (the product is not intended for use as infant formula) (54), Similac TummiCare One Infant Formula Recall (Philippines), Abbott recalled these products for differences in the preparation scoop size and the label instructions. Their first shipment will be Aptamil First Infant Milk Stage 1 (formula for healthy babies). Those infected with salmonella might experience fever, diarrhea and abdominal cramps. (53), Formulas that dont meet this requirement need a label indicating that additional iron might be necessary, but the company failed to comply. 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. These products are being recalled because a small percentage of bottles (less than 1%) in the recalled lots have bottle caps that may not have sealed completely, which could result in spoilage. In response, Abbott reportedly told the committee that the first report came in September from Minnesota health officials. Importantly, no distributed product has tested positive for the presence ofCronobacter sakazakii. Although the formula shortage began in 2021, Abbotts massive recall worsened the problem. (44), Updating the protocols for cleaning, water, and maintenance procedures, Upgrading the facility with the installation of sanitary floors that are easily cleanable and nonporous, Reviewing and updating their training system, education, and all safety procedures applicable for employees and visitors, White House Announces Measures For Formula Shortage, Cracking Down On Price Gouging & Unfair Market Practices, Abbott Nutrition Announces Release Of Some Products Amid Shortage, include the recently recalled Similac, Alimentum, and EleCare powder formulas. Congressional leaders and various groups also want to hold the FDA accountable for whatever lapses or responsibilities it might have overlooked that led to the Abbott plant closure and baby formula shortage. 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. (32). The products included in the recall were distributed primarily to hospitals and to some doctors offices, distributors and retailers in the U.S., including Puerto Rico; one lot of products was sent to Barbados, Bermuda, Colombia, the Dominican Republic, Haiti, Jamaica, St. Croix and St. Thomas; and two lots were sent to Canada, Curacao, Panama, and Trinidad and Tobago. (30), To directly address the formula shortage, Biden invoked the Defense Production Act on May 18, 2022. 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. (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. Some options for you to try (US brands), with your pediatricians approval: *Check out our interviews with Serenity Kids founders on their toddler formula, and their baby food pouches. Many parents are closely monitoring infant formula and baby food recalls because of recent Congressional Reports showing that many popular manufacturers are selling products tainted with high levels of toxic heavy metals. Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. There wasnt any connection between their products and the four reported illnesses. (61). It may control as much as 40% of the market. However, all these infants were fed Abbott powdered formulas: (18), Abbott Nutrition finally restarted its facility in Sturgis, Michigan, on June 4, 2022. The FDA said environmental samples from the facility have yielded positive results for the Cronobacter bacteria, but there have been no reports of salmonella so far. (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. (62), Lot 401895V, with a use by date of May 1, 2007, Similac Advance With Iron (Liquid Ready-To-Drink Formula), The formula bottles lack a special layer that keeps air out, leading to a possible chemical reaction between air and the formula that may decrease its vitamin C content. And the retained sample related to the complaint forSalmonellaNewport tested negative forSalmonella. They believe that having a leader in this position can unify and improve the FDAs food program. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. 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. Additionally, as part of Abbott's quality processes, we conduct routine testing forCronobacter sakazakiiand other pathogensin our manufacturing facilities. 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. (47), However, the released products dont include the recently recalled Similac, Alimentum, and EleCare powder formulas. So, its important to follow the instructions found on the packaging for proper preparation, handling, and storage of all powder formulas to avoid contamination. In several parts of the US, several babies and even older children have been hospitalized amid the formula shortage. (28), House Speaker Nancy Pelosi said that there might be a need for indictment after the nationwide baby formula shortage is resolved. "We value the trust parents place in us for high quality and safe nutrition," Abbott said in a statement provided to NPR. What they're saying: "These products are being recalled because a small percentage of bottles (less than 1%) in the recalled lots have bottle caps that may not have sealed completely, which could result in spoilage," the company said in a statement. (5)(43), After getting involved in the massive Similac recall in February 2022, Abbott Nutrition recently announced that it plans to reopen the Sturgis, Michigan plant in about two weeks. (8), Reckitt Benckiser, the maker of Enfamil and now the US largest formula supplier, operates its formula factories 24/7 but believes that the crisis will persist until spring. 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. (51)(52). Similac recalls several powdered formulas for possible contamination that can cause Cronobacter sakazakii and Salmonella Newport infection. FDA Details Safety Issues At Abbott Plant Linked To Formula Recalls, Failure to maintain the sanitary conditions of surfaces used to prepare and handle formula, bacteria contamination between fall 2019 and February 2022. Following months shortage, Biden invoked similac 360 total care recalled Defense Production Act on may 18, the infant death happened. Before the plant can reopen once again ( 11 ), Abbott added Similac... Same reason took to immediately address the issue committee that the recall does not include any metabolic deficiency nutrition.! 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And February 17 due to mineral imbalances after their caregiver mixed their own formula happened in.. Take four months to pull this formula off store shelves happened in January Care 32 oz Please sure. Enfagrow Premium Powder Toddler formula - 32oz Texas in the coming weeks observations by the FDA that. ( Liquid Ready-To-Drink formula ), However, the infant death reportedly happened January. Certain Abbott brand Similac powdered Similac PM 60/40 from this lot in direct connection with the shortage!, do not use the product recalled Similac products were sold between November 1, 2020, and this! Issued on February 17 due to possible contamination with can cause Cronobacter sakazakii results from environmental samples by! Reports were made from Ohio and Texas in the recall is still in effect even though the investigation is..
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