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. (2), Cronobacter can cause severe, life-threatening infections such as sepsis or meningitis (inflammation of the membranes protecting the brain and spine), according to the CDC (Centers For Disease Control And Prevention). Enfamil NeuroPro Sensitive 19.5 oz . The Sturgis plants reopening is expected to improve formula supplies in the market and alleviate the formula shortage problem soon. Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. (41), A spokesperson for the hospital refused to disclose the exact number of hospitalized kids but said that all had specific dietary needs. (4). (61), Similac Special Care Ready-to-Feed Premature Infant Formula Powder with Iron (2-ounce bottles), Is There A Recall On Similac Alimentum? After the recall, however, they had to try other formula options but were unable to tolerate them, leading to dehydration. 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. (2). If you have any of these products, dont feed them to your baby. 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. (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. 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. Those infected with salmonella might experience fever, diarrhea and abdominal cramps. This recall was done after the death of another infant who tested positive for Cronobacter sakazakii. One of the cases was fatal. As of May 8, 2022, market research company Datasembly estimates that 43% of the top-selling formula brands are out of stock. "We value the trust parents place in us for high quality and safe nutrition," Abbott said in a statement provided to NPR. 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. We want to extend our heartfelt sympathies to the family. The action comes after learning of the death of an infant who tested positive forCronobacter sakazakiiand who we were informed had consumed Similac PM 60/40 from this lot. Directions apply to Chrome onAndroid devices. 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. Many European formulas arent approved by the FDA, although many parents still prefer them over US brands. Theyre currently working with the FDA to implement corrective actions at the plant before they can resume production. (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. 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. (46), President Biden asked the FTC (Federal Trade Commission) to investigate and monitor the perpetrators of this illegal and predatory conduct. 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. Why did the FDA not spring into action? Similac 360 Total Care Sensitive 30.2 oz. (13), 750,000 cans of Danone formula, which is equivalent to 19 million 8-ounce bottles, will arrive from their manufacturing facility in Ireland in July. It was the facility shut down in February following the massive Similac recall. (1). This case is under investigation, and at this time the cause of the infantsCronobacter sakazakiiinfection has not been determined. (4), Thats why theres also a shortage in the store brands like. (55), Batch no. (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. Update password per the new system standards (8 Characters). Abbott has informed the FDA of this new setback and announced that formula production will likely be delayed for a few weeks. One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. Similac recalls several powdered formulas for possible contamination that can cause Cronobacter sakazakii and Salmonella Newport infection. Instead, theyll be distributed to pharmacies, hospitals, and doctors offices first. 83/ounce) Enfagrow Premium Powder Toddler Formula - 32oz . 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. Cronobacter infections are rare but can be especially dangerous for newborn babies. The products included in the recall were manufactured at our Columbus, Ohio, manufacturing facility. 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. (7), When Abbott shut down from February to June 2022, it worsened the already existing formula shortage. (28). 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. They believe that having a leader in this position can unify and improve the FDAs food program. (7). Experts point out that baby formula isnt subjected to the same high temperatures that other foods undergo to kill potentially deadly bacteria and other germs. (10), The FDA announced that they received a report of another infant death last June 10. 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. Authorities are now investigating after Cronobacter was found to have possibly contributed to the death of one of the babies. (50), The company insists that despite their products being the center of the issue, their investigations showed these arent the source of the infections. So, its important to follow the instructions found on the packaging for proper preparation, handling, and storage of all powder formulas to avoid contamination. 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. 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. Similac 360 Total Care Affected bottle and carton or case lot numbers in the US: (1) 35609N200; 38493XK00 39480N200; 420395E00 (also distributed in Puerto Rico, Trinidad & Tobago, Curacao, Barbados, St Thomas, St Croix, and Haiti) 40716N200; 42567XK00 40755N200; 43579XK00 Affected lots with the same bottle and case numbers: (1) 39633N200 40624N200 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. One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. bacteria, which caused serious infections. 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. (21), According to the FDAs food director, Susan Mayne, they were unable to fully determine if theres a match because they only had sequences from two babies. 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. Some might feel more secure choosing a well-known brand name. Although the indictment might be necessary to prevent a similar shortage from happening again, urgent action is necessary to protect the hungry, crying babies. "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. The shipment included 132 pallets of both the Nestle Health Science Alfamino Infant and the Alfamino Junior formulas. (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. (29), Califf insisted that theres a need for major improvements at the FDA, not because people were bad but because they needed the right resources and consistent leadership. (42), Crouse added that there were also some parents who watered down the formula in hopes of stretching their supply. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. (42). Details: The recall is for 2 fluid ounce/59 ml bottles that were manufactured at the companys Columbus, Ohio, manufacturing facility and distributed primarily to hospitals, doctors offices, distributors and some U.S. retailers, Abbott said. The recalled products didnt meet FDA requirements because the company didnt submit pre-market notifications. 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