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. The site is secure. (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. 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 . Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. Cronobacter infections are rare but can be especially dangerous for newborn babies. The recall was issued following consumer reports of four babies hospitalized, and one possible death due to Cronobacter. After President Joe Biden announced Operation Fly Formula, several shipments have arrived from across the world to help the US solve the formula shortage. (14)(15), 200,000 8-ounce bottles of Kendamil formulas arrived at Dulles International Airport in Virginia from the United Kingdom. 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. Their first shipment will be Aptamil First Infant Milk Stage 1 (formula for healthy babies). CNN Abbott Labs said Friday that it is recalling certain lots of 2 fluid ounce/59 milliliter bottles of Ready-to-Feed liquid formula for infants and children due to a problem with the bottle caps. (49). (7), When Abbott shut down from February to June 2022, it worsened the already existing formula shortage. Call Similac for refund processing or product replacement. 02.17.2022 - Abbott initiated a proactive, voluntary recall of powder formulas, including Similac, Alimentum and EleCare, manufactured in Sturgis, Michigan, one of the company's manufacturing facilities. (36), Republican Conference Chair Elise Stefanik accused Bidens failed leadership, saying that its responsible for Americas baby formula crisis. (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. 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. She added that buybacks were considered a form of manipulation and were illegal until 1982. After dismissal, the employee reportedly made the false allegations and submitted the false report to multiple authorities. (12), These flights will arrive starting on June 24. But it poses no immediate health risk of food poisoning. bacteria, which caused serious infections. Some brands have very similar packaging for different types of formula. (32), Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage in the US. There wasnt any connection between their products and the four reported illnesses. (21), To prevent a similar shortage from happening again, the bill also requires formula manufacturers to create a contingency plan to protect against supply disruptions in the event of a recall. These two shipments of Bubs amounted to 380,000 lbs equivalent to approximately 4 million eight-ounce bottles. . 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. 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. Have there been any formula recalls? Oz./59 mL Bottles of Ready-to-Feed Liquid Products; Recall Is Not Expected to Impact U.S. (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. The other reports were made from Ohio and Texas in the following months. (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. (56), The recall was based on an internal quality review. Safeguarding Infant Health during the Recall This is in addition to lots of Similac, Alimentumand EleCarepowder formula that were voluntarily recalled on Feb. 17. 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. (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. (1)(2), Then, ready-to-feed liquid products (product names listed below) were recalled in October over a manufacturing that might cause spoilage. If a product is included in the recall, do not use the product. Childrens Wisconsin warns that homemade formula can cause liver and/or kidney damage. 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. Enfamil NeuroPro Sensitive 19.5 oz . Heres Everything You Need To Know, Nutricia Formula Wasnt Recalled in 2022, However It Did Test Positive For Cronobacter. (31), Through the Operation Fly Formula, the first batch of formulas (78,000 lbs) arrived in the US to supply specialty infant formula. It isnt ideal for premature infants or those with digestive and metabolic issues. Bing Guan/Reuters This is subject to the FDAs approval. Driving the news: The announcement follows February's massive infant formula recall that led to a nationwide baby formula shortage. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. (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. Safety Alerts, Ready-to-feed liquid products for infants and children, An official website of the United States government, : 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. (11). (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. (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. (28), However, Abbott denies that the buyback program hurt their products safety. It may also cause bowel damage and can spread through the blood to other parts of the body. But there were no serious medical complaints reported concerning this Similac recall. This means you will no longer receive SMS notifications regarding Similac rewards or special offers. Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. 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, by Abbott Laboratories, is one of the leading infant formula brands in the US. (2). (20). , which shouldnt have been sold back to consumers at all. (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. Directions apply to Chrome onAndroid devices. (61), Similac Special Care Ready-to-Feed Premature Infant Formula Powder with Iron (2-ounce bottles), Is There A Recall On Similac Alimentum? The baby had consumed Similac PM 60/40 from this lot. 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. Only the specific brands, types, and sizes listed above are WIC approved. If you have any of these products, dont feed them to your baby. 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. (37), During the May 2022 hearing, FDA Commissioner Califf and lawmakers agreed that consolidation (strong market players taking over smaller competitions) made the US formula market more vulnerable to disruptions. (61), The contamination was attributed to a manufacturing problem, but no serious health problems were reported concerning this recall. 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. (26), However, he clarified that they wouldnt tolerate having bacteria in their plant, something that the FDA found during their investigation. (4), Thats why theres also a shortage in the store brands like. The massive recalls worsened the formula shortage in the US that first started with supply chain issues. Califf announced, instead, that Abbott could restart production in a week or two, pending safety upgrades and certifications. The U.S. Food and Drug Administration is advising consumers not to use some powdered baby formulas after identifying four bacterial infections linked to the products. A company spokesperson explained that their strong balance sheet allowed them to invest in improving their facilities even with the stock buybacks. Theyre doing it to fulfill the FDAs request. 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https://efoodalert.com/2022/06/08/nine-baby-deaths-reported-to-fda-during-abbott-nutrition-investigation/, (19) https://www.fox13news.com/news/abbotts-baby-formula-plant-reopens-how-long-before-parents-see-more-supply, (20) https://www.fox5ny.com/news/baby-formula-shortage-out-of-stock-rates, (21) https://www.npr.org/2022/05/18/1099937734/biden-invokes-defense-production-act-for-baby-formula-shortage, (22) https://www.theguardian.com/australia-news/2022/may/29/australian-company-to-ship-baby-formula-to-shortage-hit-us, (23) https://www.businessinsider.com/baby-formula-shortage-us-operation-fly-formula-royal-family-2022-5, (24) https://www.cnn.com/2022/05/16/health/abbott-formula-shortage/index.html, (25) https://www.fda.gov/news-events/press-announcements/fda-provides-new-updates-activities-mitigate-infant-formula-supply-challenges-abbott-nutrition, (26) https://www.washingtonpost.com/opinions/2022/05/21/abbott-ceo-robert-ford-formula-elevil/, (27) https://www.foodsafetynews.com/2022/05/infant-formula-producer-says-it-will-reopen-manufacturing-facility-if-court-oks-consent-decree/, (28) https://www.theguardian.com/environment/2022/may/20/abbott-baby-formula-shareholder-profits, (29) https://www.nytimes.com/2022/05/19/health/baby-formula-fda-robert-califf.html, (30) https://www.newsweek.com/nancy-pelosi-opens-door-criminal-charges-over-baby-formula-shortage-1707575, (31) https://apnews.com/article/biden-health-indianapolis-00f39fd46778ecdd543c22f3630d79ba, (32) https://www.cnn.com/2022/05/22/politics/baby-formula-us-military-aircraft/index.html, (33) https://www.whitehouse.gov/briefing-room/statements-releases/2022/05/12/fact-sheet-president-biden-announces-additional-steps-to-address-infant-formula-shortage/, (34) https://www.fox13news.com/news/nestle-flies-baby-formula-us-shortage, (35) https://www.cbsnews.com/news/baby-formula-shortage-house-passes-bills/, (36) https://www.washingtonpost.com/politics/2022/05/19/republicans-baby-formula/, (37) https://apnews.com/article/biden-covid-politics-science-e4aef87dfb74039f1612ca5279e85227, (38) https://www.reuters.com/business/retail-consumer/exclusive-french-baby-formula-maker-danone-sharply-ramps-up-us-shipments-2022-05-20/, (39) https://www.afdo.org/wp-content/uploads/2022/04/FDA-Letter-FINAL.pdf, (40) https://www.cnn.com/2022/05/18/health/memphis-children-hospitalized-formula-shortage/index.html, (41) https://www.ajc.com/news/atlanta-news/some-children-hospitalized-in-georgia-due-to-baby-formula-shortage/Y3VOBHUA4BFSPCOXZLV2C4NLLU/, (42) https://www.tmj4.com/news/i-team/babies-hospitalized-at-childrens-wisconsin-during-formula-shortage, (43) https://www.fda.gov/food/outbreaks-foodborne-illness/fda-investigation-cronobacter-infections-powdered-infant-formula-february-2022, (44) https://www.cbsnews.com/chicago/news/abbott-to-resume-production-of-baby-formula-at-sturgis-michigan-plant-after-recall/, (45) https://www.whitehouse.gov/briefing-room/statements-releases/2022/05/12/fact-sheet-president-biden-announces-additional-steps-to-address-infant-formula-shortage/, (46) https://www.wtvr.com/news/local-news/baby-formula-shortage-virginia-moms, (47) https://abbott.mediaroom.com/2022-04-29-Abbott-to-Release-Metabolic-Nutrition-Formulas, (48) https://delauro.house.gov/media-center/press-releases/icymi-delauro-shares-whistleblower-report-contaminated-infant-formula, (49) https://www.businessinsider.com/whistleblower-told-fda-infant-formula-plant-before-2-babies-died-2022-4, (50) https://www.abbott.com/corpnewsroom/nutrition-health-and-wellness/abbott-statement-on-complaint-by-former-employee.html, (51) https://abcnews.go.com/Health/wireStory/fda-details-problems-plant-recalled-baby-formula-83608810, (52) https://www.usnews.com/news/business/articles/2022-03-22/fda-details-problems-at-plant-behind-recalled-baby-formula, (53) 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