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. (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. (1)(2), Parents are advised to check the packaging of their Similac powdered formulas. hide caption. Follow the directions in the email to reset your password. (56), The formula has a much lower iron content than the concentration indicated on the label. Theyre now investigating the circumstances of the babys death. (61). Similac infant formula will be produced in "alternative product sizes and formats for delivery to retail locations, in addition to increased production throughout our global manufacturing network," Abbott said. If you have any of these products, dont feed them to your baby. This recall doesnt include any metabolic deficiency nutrition formulas, Abbott liquid formulas, or other nutrition products. Foster a culture of compliance to ensure they produce the highest quality baby formulas, Empower workers to identify and report issues that could compromise their products safety and quality. But it poses no immediate health risk of food poisoning. As of press time, Abbotts Sturgis plant remains closed. But these include Similac. (37). And the retained sample related to the complaint forSalmonellaNewport tested negative forSalmonella. When you buy through links on our site we may earn an affiliate commission. Now you can switch to digital savings by phone on your favorite formulasheres how: Thanks, but I'll stick with paper for now. (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. But with so many options available, even from the same brand, finding the right formula for your baby can be a huge challenge for many parents. (19). Aside from checking the nutritional values and ingredients, its also a good idea to monitor for infant formula product recalls. powder . because of recent Congressional Reports showing that many popular manufacturers are selling products tainted with high levels of toxic heavy metals. (1)(2), Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. This manufacturing defect may cause a decrease in the formulas vitamin C content over time. Formulas still to arrive starting in June or July: The CFIA (Canadian Food Inspection Agency) warned consumers who bought from Shoppers Drug Mart to check their products after the retail pharmacy giant accidentally sold recalled baby formulas from Abbott due to an online error. (17). This is subject to the FDAs approval. (57), This voluntary recall included up to 5 million Similac powder infant formula units in plastic containers and 8-ounce, 12.4-ounce, or 12.9-ounce cans sold in the US, Guam, Puerto Rico, and some Caribbean countries. The .gov means its official.Federal government websites often end in .gov or .mil. (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. Contact the store or manufacturer for the refund or replacement process. If your infant is experiencing symptomsrelated toCronobacterorSalmonellainfection,such as poor feeding, irritability, temperature changes, jaundice, grunting breaths, abnormal movements, lethargy, rash, or blood in the urine or stool; contact your health care provider to report their symptoms and receive immediate care. How many infants were fed contaminated formula during this time?, In a statement, Abbott Nutrition wrote that they: (50), Abbott claimed that they dismissed this former employee (the whistleblower) due to serious violations of the companys food safety policies. FDA does not endorse either the product or the company. (42). They can also find it from the list that the company later released. (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. I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. 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. Federal inspectors found several safety violations: Some employees failed to sanitize their hands. 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. 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. (32), Another shipment with 114 pallets of Gerber Good Start Extensive HA formula from the Netherlands is expected to arrive via the second flight of Operation Fly Formula. "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. 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. I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. Find the answers below. It was especially more difficult for children who need specialty formulas that were only manufactured by Abbott. (6), The US Justice Department, through its consumer protection branch, is reportedly conducting a criminal investigation over Abbotts possible role in the formula shortage. Safeguarding Infant Health during the Recall This database includes recalls from Health Canada, the Canadian Food Inspection Agency, and Transport Canada. If you still wish to opt-out, please click the button below to confirm. Cronobacter infection can be deadly, especially to newborns. Some of the hospitalized kids suffered malnutrition after taking homemade formula or other inappropriate substitutions. The recall includes these 2 fl. (32). It also does not include any amino acid-based formulas or metabolic nutrition formulas. (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. Jaundice (yellow skin and whites of the eyes). 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. If a product is included in the recall, do not use the product. 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. (6), In response, deputy commissioner Frank Yiannas of the FDAs Office of Food Policy and Response submitted his resignation, effective February 24. This investigation is ongoing. 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. Its unclear why that happened, but the FDA hasnt issued a statement regarding this possible judgment lapse. (13). They havent confirmed how many formula units have been recalled. The products included in the recall were manufactured at our Columbus, Ohio, manufacturing facility. There werent any new cases identified as part of the investigation. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Califf announced, instead, that Abbott could restart production in a week or two, pending safety upgrades and certifications. (38), To meet the demands, Enfamil production has been increased to 30%, the company added. Abbott has informed the FDA of this new setback and announced that formula production will likely be delayed for a few weeks. 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. (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. (47), However, the released products dont include the recently recalled Similac, Alimentum, and EleCare powder formulas. , which shouldnt have been sold back to consumers at all. 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. (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. (41)(42). 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. However, Califf reportedly sidestepped these questions by saying that he cant share details of the agencys ongoing investigation. Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. Click on the "Learn More" button to see lot numbers included in the recall or scroll down to Check Lot Number. (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. (44), According to Abbott Nutrition, theyll prioritize producing Alimentum, EleCare, and metabolic formulas. There isnt any recent Parents Choice formula recall (only a Walmart pull-out of Parents Choice wipes). Although its still unclear what impact this reopening might have on the baby formula shortage, Abbott Nutrition hopes that it can help improve the market supply. (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. ", 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.". (1), The company explained that some of the bottles in the recalled lots might have bottle caps that were possibly not sealed completely. The doctor explained that these kids didnt have other illnesses and could have stayed at home. (28), Two years before the recall, Abbotts net profits increased from $3.6 billion to $7.1 billion, according to Securities and Exchange Commission records. Before sharing sensitive information, make sure you're on a federal government site. So, Abbott includes this specialty product in the items being released along with these metabolic products: (47), Abbott assures consumers that these products have been tested, werent included in the recall, and comply with all the product release requirements before distribution. 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. Additionally, as part of Abbott's quality processes, we conduct routine testing forCronobacter sakazakiiand other pathogensin our manufacturing facilities. (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. The recall does not include any metabolic deficiency nutrition formulas. The whistleblower alleged that Abbott Nutrition: (48), The whistleblower claims that this report was submitted to the FDA in October 2021, several months before the deaths of the babies and the February 2022 recall. (21), Rep. Andy Harris, chair of the Appropriations subcommittee that funds the FDA, claimed that it wasnt a money problem but a leadership issue. Some brands have very similar packaging for different types of formula. (28), Also, she believes that restrictions should be imposed on companies that receive federal funding or in Abbotts case, companies whose largest customers are federal programs such as the WIC. (29), This huge increase includes a $76 million increase in food safety funding to improve technology to quickly trace the source of foodborne illnesses and other efforts to reduce toxins in food. 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. (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. 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. (32), Another one was hospitalized due to mineral imbalances after their caregiver mixed their own formula. (5)(45), The White House explains that manufacturers typically produce the same formula type in various package sizes to meet the demand. (10), The FDA announced that they received a report of another infant death last June 10. (30), She further explained that its important to solve the problem as soon as possible. 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. powdered infant formulas) was issued on February 17 due to possible contamination with. Recalls. 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%. Symptoms of a Cronobacter infection include poor feeding, jaundice and grunting breaths, according to the FDA. 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. This is in addition to lots of Similac, Alimentumand EleCarepowder formula that were voluntarily recalled on Feb. 17. If your product is affected by this recall, dont use it even if it looks alright. Similac 360 Total Care * Infant Formula is made with an exclusive blend of 5 HMO prebiotics structurally identical to those in breast milk. She encourages parents and caregivers to ask their pediatrician before giving any kind of formula substitute to their babies. First European Shipment Arrives In The US, House Passes $28 Million Emergency Spending & WIC Flexibility Bills. (55), The formula is safe to consume, but incorrect preparation using the provided scoop might not provide enough nutrients for your babys normal growth. You can check if your powdered formula is affected by inspecting the code printed near the expiration date. (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. (43). 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. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. (31). Senate To Investigate Abbotts Safety Improvements & Buyback Program, The Senate Finance Committee recently announced through Senator Ron Wyden that theyre going to investigate Abbotts investments in their plants safety improvements amid record revenues. (29). This investigation is ongoing. (32), Some children with complex medical issues have been hospitalized for malnutrition at the Childrens Healthcare of Atlanta in Georgia, with some admitted back in February after the Abbott plant was closed. One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. White House National Economic Council director Brian Deese said that the Air Force cargo plane carried 15% of the specialty medical-grade baby formula needed in the US. (35), The bill passed in the House with a large bipartisan majority vote. (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. 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. (42). Consolidation Makes Formula Market Vulnerable, Reckitt Benckiser (Mead-Johnsons Enfamil), Making Food Safety A Priority To Avoid Repeat Of Formula Crisis, Babies Hospitalized Due To Formula Shortage, Two Children Hospitalized Because Their Specialty Formula Is Out Of Stock, Babies Hospitalized For Intolerance To New Formula & Mineral Imbalances, Undisclosed Number Of Children Hospitalized in Georgia, Undisclosed Number Of Kids Hospitalized in Wisconsin, Abbott Nutrition To Reopen Sturgis Plant Involved In Recall, According to Abbott Nutrition, theyll prioritize producing, and other formulas will be next in line once production starts. ). (4), Although the February 2022 Similac recall due to bacterial infections (discussed in detail below) is among the main causes of the formula shortage, authorities explained that supply chain issues and higher demands were already causing a shortage even in 2021. However, all these infants were fed Abbott powdered formulas: (18), Abbott Nutrition finally restarted its facility in Sturgis, Michigan, on June 4, 2022. (11). Directions apply to Chrome onAndroid devices. (28), House Speaker Nancy Pelosi said that there might be a need for indictment after the nationwide baby formula shortage is resolved. 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. (1), Babies can experience vomiting, diarrhea, and gastrointestinal symptoms if they consumed the spoiled products. (7). Many formulas from name brands like Similac are designed to closely resemble breast milk. (2). (56), It affected products made at a plant in Sturgis, Michigan. Reckitt facilities can also operate at their maximum capacity following these shipments. (6), He explained that he inherited the decentralized structure of the foods program, which kept his office from functioning as an integrated team and subsequently protecting the public. All finished products are tested for Cronobacter sakazakii, Salmonella Newport and other pathogens and they must test negative before any product is released. Additionally, as part of Abbotts quality processes, we conduct routine testing for Cronobacter sakazakii and other pathogensin our manufacturing facilities. Similac issued three recall notices in 2022, involving multiple formula products. (60), According to the FDA, premature babies fed with this formula for over a month may have a higher risk of developing iron-deficiency anemia because of insufficient iron intake. (33), Formula makers quickly responded, with Nestle importing Alfamino from Switzerland and also Gerber Good Start Extensive HA from the Netherlands. Theyre currently working with the FDA to implement corrective actions at the plant before they can resume production. A review of Abbott's records show that the company has destroyed products in the past due to the presence of Cronobacter. Prevent fake or fraudulent products from reaching store shelves. (18), Similac Pro-Total Comfort (Powder) infant formula, Similac Total Comfort Easy-to-Digest Gentle Protein & Prebiotics, Abbott Reopens Formula Plant, Starts EleCare Production, Some Global Companies To Send Formulas As US Shortage Hits 70%, rates continue to rise, with the number reaching as high as 70% in the week ending on May 22, according to a report from Datasembly. (13), The company needs to conduct comprehensive testing with an independent third party to determine if the plant is safe to reopen. 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. 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