Tests of retained product samples from the recalled Similac PM 60/40 lot were negative for Cronobacter. "We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need.". (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. that first started with supply chain issues. A review of Abbott's records show that the company has destroyed products in the past due to the presence of Cronobacter. (4). 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. (41), A spokesperson for the hospital refused to disclose the exact number of hospitalized kids but said that all had specific dietary needs. (28), American Economic Liberties Project senior fellow Moe Tkacik accused companies like Abbott of using their products as a personal ATM. Similac 360 Total Care 32 oz Please be sure to carefully check the labels for the substitute formulas. If yes, what happened, and which products were included? For all feeding-related questions or questions about your childs health, contact a healthcare professional. Their first shipment will be Aptamil First Infant Milk Stage 1 (formula for healthy babies). Theyre also asking for answers to get to the bottom of the problem and to ensure that infant formula contaminations wouldnt happen again. Federal inspectors found several safety violations: Some employees failed to sanitize their hands. Recalls. The baby had consumed Similac PM 60/40 from this lot. But something must be done to correct this serious safety concern. Click on the "Learn More" button to see lot numbers included in the recall or scroll down to Check Lot Number. (32), The products originated from Zurich, Switzerland, and were trucked to Germany. 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 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. (45), As the formula shortage drove desperate parents to find online options, there were reports of products being offered on eBay for as high as $800, despite normally costing $43 to $47. "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. It was especially more difficult for children who need specialty formulas that were only manufactured by Abbott. 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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/, 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Similac recalls several powdered formulas for possible contamination that can cause Cronobacter sakazakii and Salmonella Newport infection. With the ongoing infant milk formula shortage in the US, worried parents are having difficulty finding supplies for their babies. 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. 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. They also need to promptly notify the FDA about the situation. Symptoms may include irritability with generalized tenderness. According to Abbott, it will also resume the production of Similac and other formulas as soon as possible. Many European formulas arent approved by the FDA, although many parents still prefer them over US brands. Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. However, theyre still running out of formulas. Why did it take four months to pull this formula off store shelves? Theyre currently working with the FDA to implement corrective actions at the plant before they can resume production. However, Califf reportedly sidestepped these questions by saying that he cant share details of the agencys ongoing investigation. 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., Findings released by federal safety inspectors on March 22, 2022, show that Abbotts Sturgis, Michigan manufacturing plant involved in the recent Similac recall had several safety issues. Safeguarding Infant Health during the Recall Similac, by Abbott Laboratories, is one of the leading infant formula brands in the US. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. (1), Babies can experience vomiting, diarrhea, and gastrointestinal symptoms if they consumed the spoiled products. (45), According to the White House fact sheet, some unscrupulous retailers or individuals used the formula shortage to hoard products from legitimate suppliers. 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. (43). 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. 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. Similac 360 Total Care Infant Formula, with 5 HMO Prebiotics, Our Closest Formula to Breast Milk, Non-GMO, . You can find more information about these recalls below. (28), This alarmed progressive economic advocacy group, Groundwork Collaborative. The whistleblower alleged that Abbott Nutrition: (48), The whistleblower claims that this report was submitted to the FDA in October 2021, several months before the deaths of the babies and the February 2022 recall. (34), According to a Nestle representative, these products serve a critical medical purpose because theyre for babies with cows milk protein allergies. It may control as much as 40% of the market. (42). (Liquid Ready-To-Drink Formula), The bottles had a missing special layer that keeps air out. (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. Prevent fake or fraudulent products from reaching store shelves. (19). 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. Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. This 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. If your product is affected by this recall, dont use it even if it looks alright. This manufacturing defect may cause a decrease in the formulas vitamin C content over time. (53), Also, some of the formulas have low iron levels that didnt meet the minimum of 1 mg iron per 100 calories. 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