Symptoms may include irritability with generalized tenderness. Why did the FDA not spring into action? Food safety advocates are furious over how the FDA and Abbott handled these safety issues, especially because their lapses may have caused the death of at least two babies. 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.". Agriculture Secretary Tom Vilsack explained that this first batch can provide enough formula for around 9,000 babies and 18,000 toddlers for one week. (3), Symptoms of sepsis and meningitis can include: (2). As of press time, Abbotts Sturgis plant remains closed. (32). Some might feel more secure choosing a well-known brand name. By opting-out, you are removing your phone number from your Similac profile. (33), Formula makers quickly responded, with Nestle importing Alfamino from Switzerland and also Gerber Good Start Extensive HA from the Netherlands. 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. And the retained sample related to the complaint forSalmonellaNewport tested negative forSalmonella. In several parts of the US, several babies and even older children have been hospitalized amid the formula shortage. However, the recall and Abbotts plant closure elevated Enfamil to the top spot with 50% of the market share, Reckitt Benckiser claims. At least two kids have been hospitalized in direct connection with the formula shortage. (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. (21), Thanks to these special flights, shipments that normally take two weeks can reach the US within 72 hours. (13), The company needs to conduct comprehensive testing with an independent third party to determine if the plant is safe to reopen. 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. (39). (49). (61), Similac Special Care Ready-to-Feed Premature Infant Formula Powder with Iron (2-ounce bottles), Is There A Recall On Similac Alimentum? It is therefore important to verify the product lot number on the bottom or the side of the bottle. She encourages parents and caregivers to ask their pediatrician before giving any kind of formula substitute to their 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. (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. Theyre doing it to fulfill the FDAs request. (40), They relied on the amino acids (building blocks of proteins) from EleCare for nourishment because these dont have to be digested. Before sharing sensitive information, make sure you're on a federal government site. The massive recalls worsened the formula shortage in the US that first started with supply chain issues. (42), Crouse added that there were also some parents who watered down the formula in hopes of stretching their supply. 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. Similac Formula Recall Washington WIC - Temporary Choices for Infant Formula November 1 , 2022 1 Similac Formula Recall - November 1, 2022 . (21), Abbott reportedly enjoyed profits soaring as high as 94% between 2019 and 2021 even as bacteria was detected in its products during the same period. 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 So, major disruptions of these companies supplies, such as a massive recall like the February 2022 Similac recall, can greatly affect the formula supply in the market. Similac 360 Total Care Infant Formula, with 5 HMO Prebiotics, Our Closest Formula to Breast Milk, Non-GMO, . 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). She added that buybacks were considered a form of manipulation and were illegal until 1982. This recall doesnt include any metabolic deficiency nutrition formulas, Abbott liquid formulas, or other nutrition products. 02.28.2022 UPDATE: Abbott is voluntarily recalling one lot of Similac PM 60/40 (Lot #27032K80 (can) / Lot # 27032K800 (case)) manufactured in Sturgis, Michigan. According to Abbott, it will also resume the production of Similac and other formulas as soon as possible. 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. The .gov means its official.Federal government websites often end in .gov or .mil. There werent any new cases identified as part of the investigation. This case is under investigation, and at this time the cause of the infantsCronobacter sakazakiiinfection has not been determined. (41)(42). Cronobacter infection can be deadly, especially to newborns. 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. Recalled products can be identified by the 7 to 9 digit code and expiration date on. (28), However, Abbott denies that the buyback program hurt their products safety. (5), Last month, an independent outside review requested by FDA Commissioner Robert Califf slammed the agencys response to the Similac food recall and the formula shortage. Photo: Stefani Reynolds / AFP via Getty Images. 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. It was the facility shut down in February following the massive Similac recall. 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. (51)(52). We found no evidence ofSalmonellaNewport. There wasnt any connection between their products and the four reported illnesses. 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. "We value the trust parents place in us for high quality and safe nutrition," Abbott said in a statement provided to NPR. 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. (6), The US Justice Department, through its consumer protection branch, is reportedly conducting a criminal investigation over Abbotts possible role in the formula shortage. (32), Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage in the US. (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. Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. The FDA had actually conducted plant inspections in September. 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. This can result in spoilage. It also called for the appointment of a strong leader and the reorganization of the FDAs food program. (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. (1). This database includes recalls from Health Canada, the Canadian Food Inspection Agency, and Transport Canada. (32), The products originated from Zurich, Switzerland, and were trucked to Germany. With the ongoing infant milk formula shortage in the US, worried parents are having difficulty finding supplies for their babies. 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. (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. (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. If a product is included in the recall, do not use the product. Many formulas from name brands like Similac are designed to closely resemble breast milk. Tests of retained product samples from the recalled Similac PM 60/40 lot were negative for Cronobacter. ). (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. (32), Another one was hospitalized due to mineral imbalances after their caregiver mixed their own formula. After dismissal, the employee reportedly made the false allegations and submitted the false report to multiple authorities. that first started with supply chain issues. 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. The USDA (United States Department of Agriculture) is also coordinating with various states to let WIC recipients purchase whatever products are in stock instead of being limited to WIC-approved options. Similac 360 Total Care 32 oz Please be sure to carefully check the labels for the substitute formulas. Cronobacter infections are rare but can be especially dangerous for newborn babies. The site is secure. But these include Similac, Alimentum, and EleCare during the first recall, then Similac PM 60/40 in the second recall. (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. You can find more information about these recalls below. However, all these infants were fed Abbott powdered formulas: (18), Abbott Nutrition finally restarted its facility in Sturgis, Michigan, on June 4, 2022. 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. (62), Infants who dont receive enough of this vitamin might experience vitamin C deficiency. While Abbott's testing of distributed product detected no pathogens, we are taking action by recalling the powder formula manufactured in this facility with an expiration of April 1, 2022, or later. Some brands have very similar packaging for different types of formula. 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. It also does not include any amino acid-based formulas or metabolic nutrition formulas. Bing Guan/Reuters He admitted to reading the complaint but didnt specify when or what steps he took to immediately address the issue. It also does not include any amino acid-based formulas or metabolic nutrition formulas. (18), None of the DNA sequences in the FDA investigation matched the companys products. They can also find it from the list that the company later released. Affected customers were advised to search for the lot number of their item at similac.com/recall. (28), House Speaker Nancy Pelosi said that there might be a need for indictment after the nationwide baby formula shortage is resolved. (2)(3). 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. Their first shipment will be Aptamil First Infant Milk Stage 1 (formula for healthy babies). Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. Thankfully, the children have all been discharged. 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. (55), Batch no. (61), The contamination was attributed to a manufacturing problem, but no serious health problems were reported concerning this recall. "We'll do whatever it takes to keep that trust and resolve this situation. (31), Aside from ramping up productions, Biden also launched Operation Fly Formula. He directed various government agencies to use the Department of Defense planes to pick up formulas that meet U.S. standards overseas and fly these to the U.S. to help restock shelves. (11), According to the FDA, the infant death reportedly happened in January. It will take around three weeks or June 20 before these formulas will hit market shelves. To identify if your product is included, please visit similacrecall.com to view a list of impacted lot numbers or use the lot number checker on the webpage. (11). Although the formula shortage began in 2021, Abbotts massive recall worsened the problem. (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. Substitute to their babies Breast Milk products can be deadly, especially to newborns sakazakiiinfection not! Lot were negative for cronobacter a federal government site a manufacturing problem but... 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