(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). 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 . (56), It affected products made at a plant in Sturgis, Michigan. (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 yes, what happened, and which products were included? "We value the trust parents place in us for high quality and safe nutrition," Abbott said in a statement provided to NPR. (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. Thankfully, the children have all been discharged. Inspect domestic and international suppliers. Several groups are also calling on the FDA to restore the deputy food commissioner position removed during the Trump administration. 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 , It was easier to increase the shipments because both were already being imported even before the shortage. (32), Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage in the US. Thats why theres also a shortage in the store brands like Walmarts Parents Choice formulas produced by Perrigo. (11). because of recent Congressional Reports showing that many popular manufacturers are selling products tainted with high levels of toxic heavy metals. (21), Democrat Rep. Rosa DeLauro, the chair of the House Appropriations Committee, explained that this will increase the FDAs staff so more of them can do the following: (21), However, this bill has been met with resistance, with other lawmakers such as Rep. Bill Huizenga saying that more formula production is needed, not more FDA staff. Similac issued three recall notices in 2022, involving multiple formula products. Learn More. It isnt ideal for premature infants or those with digestive and metabolic issues. (26), He explained that none of the data matched between the specimen from the four complaints and of the retained product samples. 360 Whole-Baby Support: Nutrition designed for immune support, brain development, and digestive health; Helps Strengthen the Immune System: Similac 360 Total Care is designed to help strengthen baby's immune system; Convenient & Ready to Use: Great for on-the-go and late-night feeding; no mixing required Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. (47), Abbott explains that the nutrition formulas will be released free of charge to patients but on a case-by-case basis and in coordination with healthcare professionals. "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. (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. Our formula also has nutrition designed for immune support, brain development, and digestive health. (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. This voluntary recall only affected products sold in the Philippines. Why did the FDA not spring into action? (13), The company needs to conduct comprehensive testing with an independent third party to determine if the plant is safe to reopen. (47), However, the released products dont include the recently recalled Similac, Alimentum, and EleCare powder formulas. Yes, but: Lot numbers of the affected products are listed at Similacrecall.com. (31), However, these specialty formulas arent expected to hit retail store shelves. 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. 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. (3), Symptoms of sepsis and meningitis can include: (2). Designed to support the immune system, brain development, and digestive health. According to Abbott, it will also resume the production of Similac and other formulas as soon as possible. (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. Abbott assured the public that they are taking this very seriously and working closely with the FDA to implement corrective actions. (51)(52). Similac recalls several powdered formulas for possible contamination that can cause Cronobacter sakazakii and Salmonella Newport infection. It may also cause bowel damage and can spread through the blood to other parts of the body. (28), This alarmed progressive economic advocacy group, Groundwork Collaborative. 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. . (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. 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. With the ongoing infant milk formula shortage in the US, worried parents are having difficulty finding supplies for their babies. For all feeding-related questions or questions about your childs health, contact a healthcare professional. The recall includes these 2 fl. (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. Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. 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. The Sturgis plants reopening is expected to improve formula supplies in the market and alleviate the formula shortage problem soon. The shipment included 132 pallets of both the Nestle Health Science Alfamino Infant and the Alfamino Junior formulas. Theyre now investigating the circumstances of the babys death. We found no evidence ofSalmonellaNewport. Safeguarding Infant Health during the Recall (26), However, he clarified that they wouldnt tolerate having bacteria in their plant, something that the FDA found during their investigation. The Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. (31), This next shipment from Ramstein Air Base is expected to land in Pennsylvania for distribution by the Nestle facility in the area. (38), During the hearing before the House subcommittee, Califf asked lawmakers to increase the agencys budget from last years $2.1 billion to $8.4 billion for food safety and nutrition. 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. 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. Some of the hospitalized kids suffered malnutrition after taking homemade formula or other inappropriate substitutions. (7), When Abbott shut down from February to June 2022, it worsened the already existing formula shortage. 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. (5)(45), The White House explains that manufacturers typically produce the same formula type in various package sizes to meet the demand. Additionally, as part of Abbotts quality processes, we conduct routine testing for Cronobacter sakazakii and other pathogensin our manufacturing facilities. One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. (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. Theyre doing it to fulfill the FDAs request. (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. (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. Update password per the new system standards (8 Characters). However, she warned that formula dilution can lead to organ failure or brain swelling. (53), Formulas that dont meet this requirement need a label indicating that additional iron might be necessary, but the company failed to comply. The case remains under investigation, with authorities still trying to determine the cause of the infants Cronobacter sakazakii infection. 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. Abbott Recalls Ready-to-Feed Liquid Products, 39480N200; 420395E00 (also distributed in Puerto Rico, Trinidad & Tobago, Curacao, Barbados, St Thomas, St Croix, and Haiti), 40561N200 (also sold in Puerto Rico, Curacao, Jamaica, Bermuda, and Trinidad & Tobago), 40749N200 sold in the Dominican Republic, 39398N200 (bottle lot number only) sold in Canada, Similac Recall February 2022 (Second Recall), This recall was done after the death of another infant who tested positive for. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. Liquid baby formula and all other products produced by Abbott Nutrition are not affected. Additionally, retained samples related to the three complaints forCronobacter sakazakiitested negative forCronobacter. It was the facility shut down in February following the massive Similac recall. (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. (56), The formula has a much lower iron content than the concentration indicated on the label. Follow the directions in the email to reset your password. Similac 360 Total Care * Infant Formula is made with an exclusive blend of 5 HMO prebiotics structurally identical to those in breast milk. The recall does not include any metabolic deficiency nutrition formulas. Although the indictment might be necessary to prevent a similar shortage from happening again, urgent action is necessary to protect the hungry, crying babies. 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. It was also quickly approved by the Senate and is now up to Biden to sign into law. 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. 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. Understanding the need for the international community to help solve the US crisis as more babies go hungry, several foreign baby formula companies offered to help. (24)(25), These are some of the steps they need to comply with: (24)(25), The company must also review and change the following: (24), If any contamination is detected, Abbott is required to immediately stop production. Then, theyre marking these up for online retail at exorbitant prices. However, issuing the voluntary recall was the right thing to do because they didnt want to risk the childrens lives and health. They can also find it from the list that the company later released. (31). (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). (1)(2), Then, ready-to-feed liquid products (product names listed below) were recalled in October over a manufacturing that might cause spoilage. 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. After dismissal, the employee reportedly made the false allegations and submitted the false report to multiple authorities. (48), DeLauro expressed alarm that the FDA didnt act quickly enough to check on the whistleblowers report, considering that it involves the possible unsafe production of infant formula. Some of the companies that offered to help: A consent decree filed at the US District Court for the Western District of Michigan created a legally binding agreement between Abbott and the FDA, with steps that the company had to comply with before production at the Sturgis facility can resume. (61), Similac Special Care Ready-to-Feed Premature Infant Formula Powder with Iron (2-ounce bottles), Is There A Recall On Similac Alimentum? Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. It will take around three weeks or June 20 before these formulas will hit market shelves. Groups are calling on FDA officials to make food safety a priority to avoid a repeat of the formula crisis. (13). You can find more information about these recalls below. 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. Federal inspectors found several safety violations: (43)(51)(52). (Liquid Ready-To-Drink Formula), The bottles had a missing special layer that keeps air out. (34), According to a Nestle representative, these products serve a critical medical purpose because theyre for babies with cows milk protein allergies. (55), Batch no. The company clarified that these products are only available in limited quantities because production hasnt resumed at the Sturgis facility. (12), These flights will arrive starting on June 24. Abbott has informed the FDA of this new setback and announced that formula production will likely be delayed for a few weeks. If you have any of these products, dont feed them to your baby. (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. They also need to promptly notify the FDA about the situation. Otherwise, click Cancel to return to your profile. Abbott Nutrition acknowledges their role in the infant formula shortage. FDA Commissioner Dr. Robert Califf is the first administration official to face Congress in an investigation of the baby formula shortage. Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. (1), The company explained that some of the bottles in the recalled lots might have bottle caps that were possibly not sealed completely. However, although the second bill (emergency spending bill) was also passed, it was received with more resistance from Republican representatives. (50). Theyre currently working with the FDA to implement corrective actions at the plant before they can resume production. hide caption. 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. (45), According to the White House fact sheet, some unscrupulous retailers or individuals used the formula shortage to hoard products from legitimate suppliers. Still, parents are also having trouble finding these products for their babies. These were loaded on one C-17 cargo plane at Ramstein Air Base in Germany and flown to Indianapolis. (58), Abbott Laboratories Inc. assured affected customers that their tests showed only 0.16% of the recalled Similac products were contaminated. The first administration official to face Congress in an investigation of the Department Agriculture. 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