powder . (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. But these include Similac. The company assures consumers that they have improved their protocols and systems at 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 . First European Shipment Arrives In The US, House Passes $28 Million Emergency Spending & WIC Flexibility Bills. This investigation is ongoing. . 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. (1). The FDA relaxed some regulations to make it easier for foreign companies to import formulas to the US, while also assuring parents that these products meet US standards. Recalls, Market Withdrawals, & Safety Alerts, Recalls, Market Withdrawals and Safety Alerts, Recalls, Market Withdrawals, & Safety Alerts, Archive for Recalls, Market Withdrawals & Safety Alerts, Abbott Voluntarily Recalls Certain Lots of 2 Fl. If a product is included in the recall, do not use the product. 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. (1)(2), Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. 02.17.2022 -Abbott initiated a proactive, voluntary recall of powder formulas, including Similac, Alimentumand EleCare,manufactured in Sturgis, Michigan, one of the companys manufacturing facilities. Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. Dr. Mark Corkins, a pediatric gastroenterologist at Le Bonheur Childrens Hospital in Memphis, Tennessee, revealed that he admitted two patients because their specialty formula is out of stock. Why it matters: About 3 in 4 babies are fed formula by six months old as a complete or partial substitute for human milk, Axios' Nathan Bomey reports. (6), In response, deputy commissioner Frank Yiannas of the FDAs Office of Food Policy and Response submitted his resignation, effective February 24. Symptoms may include irritability with generalized tenderness. The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. The company announced that it will prioritize EleCare production as well as other specialty and metabolic formulas for babies with severe food allergies and digestive problems. Additionally, as part of Abbotts quality processes, we conduct routine testing for Cronobacter sakazakii and other pathogensin our manufacturing facilities. (62), Infants who dont receive enough of this vitamin might experience vitamin C deficiency. Similac, by Abbott Laboratories, is one of the leading infant formula brands in the US. Why did the FDA not spring into action? Instead, theyll be distributed to pharmacies, hospitals, and doctors offices first. (40), The two children (a toddler and a preschooler) were using EleCare, a specialty formula they needed because they both have short bowel syndrome and couldnt absorb full-size proteins. , which shouldnt have been sold back to consumers at all. (11). iPhone users should open in Safari. 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. Double-check the full product name, lot code, batch number, and the expiration or use by date. (56), The recall was based on an internal quality review. (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. Call Similac for refund processing or product replacement. However, even with the plants reopening, Abbott Nutrition estimates that the new products will only reach the store shelves in around six to eight weeks. There wasnt any connection between their products and the four reported illnesses. After dismissal, the employee reportedly made the false allegations and submitted the false report to multiple authorities. Abbott said it would restart EleCare production, upon reopening, followed by specialty and metabolic formulas. If you have questions, please contact Abbott's Consumer Relations hotlines below in the country where you received product: More Recalls, Market If you have questions, please contact Abbott's Consumer Relations hotlines below in the country where you received product: Join Similac Rewards for up to $400*in benefits and support throughout your journey. 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. In response, Abbott reportedly told the committee that the first report came in September from Minnesota health officials. (11), According to the FDA, the infant death reportedly happened in January. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. Why it matters: About 3 in 4 babies are fed formula by six months old as a complete or partial substitute for human milk, Axios' Nathan Bomey reports. (21), Thanks to these special flights, shipments that normally take two weeks can reach the US within 72 hours. This is subject to the FDAs approval. The FDA had actually conducted plant inspections in September. If your product is affected by this recall, dont use it even if it looks alright. However, she warned that formula dilution can lead to organ failure or brain swelling. Around 50% of the market demand comes from the WIC program (Special Supplemental Nutrition Program for Women, Infants, and Children). (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. Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. Yes, but: Lot numbers of the affected products are listed at Similacrecall.com. All finished infant formula powder products are tested forCronobacter,Salmonella,and other pathogens, and they must test negative before the product is released. Similac 360 Total Care Milk-based infant formula with iron A 20 Cal/fl oz, nutritionally complete, non-GMO, milk-based, iron fortified infant formula designed to support the immune system, brain development and digestive health. (25), Abbott Laboratories CEO Robert Ford apologized for their role in the formula shortage, referring to the massive recall of Similac, Elecare, and Alimentum products in February 2022. Oz./59 mL Bottles of Ready-to-Feed Liquid Products; Recall Is Not Expected to Impact U.S. . 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. (42). (44), According to Abbott Nutrition, theyll prioritize producing Alimentum, EleCare, and metabolic formulas. (4). The White House recently announced Operation Fly Formulas tenth flight to Fort Worth, Texas from Mexico, which will bring approximately 1 million pounds (equivalent to around 16 million 8-oz bottles) of Gerber Good Start Gentle infant formula. 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). According to Abbott, it will also resume the production of Similac and other formulas as soon as possible. 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 Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. Heres the statement from Abbott regarding this recall: 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. However, issuing the voluntary recall was the right thing to do because they didnt want to risk the childrens lives and health. 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. With the ongoing infant milk formula shortage in the US, worried parents are having difficulty finding supplies for their babies. Many European formulas arent approved by the FDA, although many parents still prefer them over US brands. 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. (47). (53), Also, some of the formulas have low iron levels that didnt meet the minimum of 1 mg iron per 100 calories. Additionally, retained samples related to the three complaints forCronobacter sakazakiitested negative forCronobacter. (1). In several parts of the US, several babies and even older children have been hospitalized amid the formula shortage. Thats why theres also a shortage in the store brands like Walmarts Parents Choice formulas produced by Perrigo. Abbott is voluntarily recalling these products after four consumer complaints related toCronobacter sakazakiiorSalmonellaNewport in infants who had consumed powder infant formula manufactured in this facility. (42), Crouse added that there were also some parents who watered down the formula in hopes of stretching their supply. Safety Alerts, Ready-to-feed liquid products for infants and children, An official website of the United States government, : 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 , They established an IMG (Incident Management Group) to continue working on these supply chain and food safety issues as the out-of-stock rates soared to 43%. They also need to promptly notify the FDA about the situation. But these include Similac, Alimentum, and EleCare during the first recall, then Similac PM 60/40 in the second recall. (1). A review of Abbott's records show that the company has destroyed products in the past due to the presence of Cronobacter. These were loaded on one C-17 cargo plane at Ramstein Air Base in Germany and flown to Indianapolis. 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. One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. (56), The Similac recall involved dozens of different lots and products. Federal inspectors found several safety violations: (43)(51)(52). Recalls. Contains no artificial growth hormones and is non-GMO. Republicans are questioning why the FDA isnt held accountable for the shortage and the possible lapses that led to the deaths of the two babies linked to the Abbott products. (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). Falsified records about several safety and quality concerns, including signing verifications without adequate knowledge, testing of seals, shipping products with fill weights lower than whats on the label, failure to maintain accurate maintenance records, etc. (29). 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. He admitted to reading the complaint but didnt specify when or what steps he took to immediately address the issue. 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. (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. . Recalled products can be identified by the 7 to 9 digit code and expiration date on. 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. (2). According to the hospital spokesperson, the kids ranged from babies to older children. 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. 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. Childrens Wisconsin warns that homemade formula can cause liver and/or kidney damage. (26), Abbotts head detailed the serious steps the company is taking to address the baby formula shortage: (26), Once the production resumes at Sturgis, Michigan, Ford detailed that they will do the following: (26), While Abbott maintains that the strains from the FDAs investigations dont match those taken from their facility, FDA officials recently refuted this claim. Abbott Nutrition issued a voluntary recall of certain lots of ready-to-feed liquid products (2 fl oz or 59 ml bottles), produced at their manufacturing facility in Columbus, Ohio, due to a manufacturing defect. (40), They relied on the amino acids (building blocks of proteins) from EleCare for nourishment because these dont have to be digested. Surprisingly, however, the FDA didnt issue a safety notice nor did they stop Abbott from producing formulas until the issues have been resolved. (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. (30), To directly address the formula shortage, Biden invoked the Defense Production Act on May 18, 2022. On February 18, Abbott brand powdered infant formula products sold across the country have been flagged and recalled by the CIFA as there is the possibility of Cronobacter sakazakii and . 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. The recall does not include any metabolic deficiency nutrition formulas. Before sharing sensitive information, make sure you're on a federal government site. 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. (21), According to the FDAs food director, Susan Mayne, they were unable to fully determine if theres a match because they only had sequences from two babies. 2 fl oz ready-to-feed liquid products included in this voluntary recall: Its important to note that not all recalled products were distributed in all countries and not all 2 fl oz/59 ml formulas are included in the recall. But it poses no immediate health risk of food poisoning. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. This can result in spoilage. Theyre now investigating the circumstances of the babys death. (1)(2), Parents are advised to check the packaging of their Similac powdered formulas. Authorities are now investigating after Cronobacter was found to have possibly contributed to the death of one of the babies. However, the baby formula shortage from supply chain issues and the Similac recalls reduced the available products. (47), Whistleblower Reportedly Notified The FDA About Security Lapses Months Before Recall, Hid information during a 2019 audit by the FDA (Food and Drug Administration). (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. 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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(1), The company explained that some of the bottles in the recalled lots might have bottle caps that were possibly not sealed completely. The site is secure. (15), 686,350 cans equivalent to approximately 16.5 million 8 fl oz bottles of Similac NeoSure (for premature babies or low birthweight infants) and Similac Total Comfort (for infants with sensitive tummies) will be imported by Abbott from their manufacturing facility in Granada, Spain, starting in June and throughout the summer. Similac is among the most popular formula brands, but is it a healthy option for your baby? "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. 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. 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. I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. Moms may have different reasons for choosing a particular formula for their babies. (29), Wyden has reportedly requested Abbott for more information regarding their stock buyback program. Experts point out that baby formula isnt subjected to the same high temperatures that other foods undergo to kill potentially deadly bacteria and other germs. (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. During testing in our Sturgis, Michigan, facility, we found evidence ofCronobacter sakazakiiin the plant in non-product contact areas. However, theyre still running out of formulas. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. Similac 360 Total Care 32 oz Please be sure to carefully check the labels for the substitute formulas. More are expected to arrive on three more flights in the coming weeks. ", What's next: The company said it 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. However, Califf reportedly sidestepped these questions by saying that he cant share details of the agencys ongoing investigation. (21), Under this act, suppliers must prioritize orders from infant formula manufacturers before any of their other customers who may have ordered the same goods. (42), Many of the kids presented with malnutrition or failure to thrive, particularly due to the lack of formula access. (1), According to the recall advisory, these are the affected products: (1), Abbott Nutrition clarified that only a small percentage of bottles might have been affected by the manufacturing defect. (16), Recalled Baby Formula Accidentally Sold In Canada, The first two digits are numbers from 22 to 37, The expiration date code starts from 4-1-2022 (APR 2022) and subsequent dates. (42). 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 SimilacPro-Total ComfortTM, Similac360 Total Care, Similac 360 Total Care Sensitive, SimilacSpecial Care24, Similac Stage 1, SimilacNeoSure, Similac Water (Sterilized) and Pedialyte Electrolyte Solution. Although the indictment might be necessary to prevent a similar shortage from happening again, urgent action is necessary to protect the hungry, crying babies. Many formulas from name brands like Similac are designed to closely resemble breast milk. (53), Formulas that dont meet this requirement need a label indicating that additional iron might be necessary, but the company failed to comply. Importantly, no distributed product has tested positive for the presence ofCronobacter sakazakii. (28), House Speaker Nancy Pelosi said that there might be a need for indictment after the nationwide baby formula shortage is resolved. (27), According to Ford, none of the bacterial strains that caused the infection of four infants, killing two babies, were found in Abbotts products. (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. 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