(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. You can find more information about these recalls below. If you have any of these products, dont feed them to your baby. (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. 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. Similac 360 Total Care Sensitive 30.2 oz. After dismissal, the employee reportedly made the false allegations and submitted the false report to multiple authorities. (61), Similac Special Care Ready-to-Feed Premature Infant Formula Powder with Iron (2-ounce bottles), Is There A Recall On Similac Alimentum? Recalled products can be identified by the 7 to 9 digit code and expiration date on. 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. According to Abbott, it will also resume the production of Similac and other formulas as soon as possible. (21), Thanks to these special flights, shipments that normally take two weeks can reach the US within 72 hours. She encourages parents and caregivers to ask their pediatrician before giving any kind of formula substitute to their babies. 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. It isnt ideal for premature infants or those with digestive and metabolic issues. However, the recall and Abbotts plant closure elevated Enfamil to the top spot with 50% of the market share, Reckitt Benckiser claims. The recall does not include any metabolic deficiency nutrition formulas. 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. 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. They havent confirmed how many formula units have been recalled. that first started with supply chain issues. But it poses no immediate health risk of food poisoning. Similac recalls several powdered formulas for possible contamination that can cause Cronobacter sakazakii and Salmonella Newport infection. Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage in the US. 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. 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: (2). And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella Newport, Abbott also reminds parents and caregivers that, can be commonly found in the environment and a variety of areas around the home. Those infected with salmonella might experience fever, diarrhea and abdominal cramps. (42), Crouse added that there were also some parents who watered down the formula in hopes of stretching their supply. Select Similac baby products are part of a new recall. 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. 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. ). The baby had consumed Similac PM 60/40 from this lot. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. (49). (28), Then, the company allegedly increased its dividends by over 25% and offered shareholders a stock buyback program worth $5 billion. (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. In response, Abbott reportedly told the committee that the first report came in September from Minnesota health officials. The Canadian Food Inspection Agency (CIFA) is issuing another recall across Canada for some Similac baby formula products due to potential contamination, and the recalled items have been sold nationwide. 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 . (33), Formula makers quickly responded, with Nestle importing Alfamino from Switzerland and also Gerber Good Start Extensive HA from the Netherlands. Their first shipment will be Aptamil First Infant Milk Stage 1 (formula for healthy babies). (20), Bubs Australia at least 1.25 million cans of baby formula (22), UK manufacturer Kendal Nutricare (makers of Kendamil) around 100 trucks over the next six months (23), Abbott Needs To Comply With Court Consent Decree Before Production Can Resume, Hiring an independent third party expert who will review its processes, Cleaning and sanitizing the entire facility, including all equipment, Restarting all the equipment and completing test runs, Conducting multiple tests of all equipment, Abbotts Serious Steps To Address The Formula Shortage, Creating a $5 million fund for children hospitalized due to lack of access to specialized products, Converting production lines at their Columbus, Ohio, facility to prioritize the production of ready-to-feed liquid infant formula, Air-shipping millions of widely used powdered baby formulas from an FDA-approved plant in Ireland to the US, More than double the current production to help produce more products to address the shortage, Make significant investments to improve facilities to ensure the issue doesnt happen again, Invest in upgrading safety and quality processes and equipment, FDA Refutes Abbotts Claim Regarding Bacterial Strains, Groups Claim Abbott Enriched Shareholders While Plant Needed Repairs, Pelosi Eyes Criminal Charges Over Baby Formula Shortage, For Abbott Nutrition raw materials like sugar and corn syrup for infant formula, For Reckitt filters and other single-use products to generate certain oils needed in their infant formula production, Formula Makers Import European Stocks To Help With US Shortage. "We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need.". It also does not include any amino acid-based formulas or metabolic nutrition formulas. As of press time, Abbotts Sturgis plant remains closed. Similac issued three recall notices in 2022, involving multiple formula products. Contact the store or manufacturer for the refund or replacement process. In several parts of the US, several babies and even older children have been hospitalized amid the formula shortage. 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. (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. The Sturgis plants reopening is expected to improve formula supplies in the market and alleviate the formula shortage problem soon. 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. 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 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. It was easier to increase the shipments because both were already being imported even before the shortage. 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 (34), They have also increased production and worked round the clock to help meet the demand. Similac 360 Total Care * Infant Formula is made with an exclusive blend of 5 HMO prebiotics structurally identical to those in breast milk. This voluntary recall only affected products sold in the Philippines. Scott Stoffel, Abbotts spokesperson, confirmed that theyve been informed about the Justice Departments investigation and are cooperating fully. (7), It has been almost a year since the formula shortage crisis began in the US, yet it still persists despite efforts from the government and formula makers. Driving the news: The announcement follows February's massive infant formula recall that led to a nationwide baby formula shortage. 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. (40), They relied on the amino acids (building blocks of proteins) from EleCare for nourishment because these dont have to be digested. 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 . (10), The agency announced that it will issue further guidance in September regarding how these companies could meet their requirements to continue supplying formulas beyond mid-November. (44). (26), He explained that none of the data matched between the specimen from the four complaints and of the retained product samples. 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 Cronobacter sakazakii infections that led to the February 2022 Similac recall. (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. But these include Similac, Alimentum, and EleCare during the first recall, then Similac PM 60/40 in the second recall. (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. Before sharing sensitive information, make sure you're on a federal government site. Retail companies like Walmart have already put a cap on how many you can buy per transaction. 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. (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), She further explained that its important to solve the problem as soon as possible. (18), None of the DNA sequences in the FDA investigation matched the companys products. (12), These flights will arrive starting on June 24. Similac, by Abbott Laboratories, is one of the leading infant formula brands in the US. He admitted to reading the complaint but didnt specify when or what steps he took to immediately address the issue. 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 , . (31), Through the Operation Fly Formula, the first batch of formulas (78,000 lbs) arrived in the US to supply specialty infant formula. Authorities are now investigating after Cronobacter was found to have possibly contributed to the death of one of the babies. Click Here for Recall Information: 2 fl oz Ready-to-Feed Liquid Recall (Oct 2022) or Powder Formula Recall (Feb 2022). (32), Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage in the US. Additionally, retained samples related to the three complaints forCronobacter sakazakiitested negative forCronobacter. (53), Formulas that dont meet this requirement need a label indicating that additional iron might be necessary, but the company failed to comply. (58), Abbott Laboratories Inc. assured affected customers that their tests showed only 0.16% of the recalled Similac products were contaminated. Recalls. Tests of retained product samples from the recalled Similac PM 60/40 lot were negative for Cronobacter. Lax practices in terms of clean in place procedures, Failed to take corrective measures after knowing their testing procedures were deficient, Had an atmosphere of retaliation against employees who raised concerns about their company practices. (30), To directly address the formula shortage, Biden invoked the Defense Production Act on May 18, 2022. It was especially more difficult for children who need specialty formulas that were only manufactured by Abbott. (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. FDA Commissioner Dr. Robert Califf is the first administration official to face Congress in an investigation of the baby formula shortage. Many European formulas arent approved by the FDA, although many parents still prefer them over US brands. 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. Once they get the FDAs go-signal, Abbott will return to EleCare production before restarting Similac and other formula lines. Still, the experience pushed economists to call for bans on buybacks, stricter antitrust enforcement, and limits on shareholder dividends. Priority will be given to worst-hit regions, a Biden administration official said. Yes. As of May 8, 2022, market research company Datasembly estimates that 43% of the top-selling formula brands are out of stock. All finished infant formula powder products are tested forCronobacter,Salmonella,and other pathogens, and they must test negative before the product is released. 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). (20). 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. 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