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(6), In response, deputy commissioner Frank Yiannas of the FDAs Office of Food Policy and Response submitted his resignation, effective February 24. These products were manufactured at the companys Columbus, Ohio, manufacturing facility and distributed primarily to hospitals, doctors offices, distributors, and some retailers in the US, including Puerto Rico; a limited number of products were sent to Canada, Colombia, the Dominican Republic, Panama, and certain countries in the Caribbean. This is subject to the FDAs approval. 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 Oz./59 mL Bottles of Ready-to-Feed Liquid Products; Recall Is Not Expected to Impact U.S. Similac, by Abbott Laboratories, is one of the leading infant formula brands in the US. Similac 360 Total Care Milk-based infant formula with iron A 20 Cal/fl oz, nutritionally complete, non-GMO, milk-based, iron fortified infant formula designed to support the immune system, brain development and digestive health. (51)(52), The FDAs preliminary findings show the following: (51)(52), The Senate health committee asked Abbott to detail the amount of time it took them to start the recall from the first reported case. Retail companies like Walmart have already put a cap on how many you can buy per transaction. (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. "We value the trust parents place in us for high quality and safe nutrition," Abbott said in a statement provided to NPR. 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. 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. Abbott is voluntarily recalling these products after four consumer complaints related toCronobacter sakazakiiorSalmonellaNewport in infants who had consumed powder infant formula manufactured in this facility. (56), Call 800-986-8850 or visit similac.com/recall (the companys website for recalls), Similac Go & Grow Milk Early Shield Powder, When we identified this, we did extensive testing of every product on the (factory) line, and more than 99.8 percent of the product was negative for beetle contamination, , said Abbott spokeswoman Melissa Brotz. "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. (47). RECALL NOTICE: OUTSIDE US October 2022 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 brands Similac Pro-Total Comfort , Similac 360 Total Care , Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Stage 1, Similac Water (Sterilized), Similac Neosure and . Some brands have very similar packaging for different types of formula. (48). (1), The company explained that some of the bottles in the recalled lots might have bottle caps that were possibly not sealed completely. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. (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. (61). It also does not include any amino acid-based formulas or metabolic nutrition formulas. As of May 8, 2022, market research company Datasembly estimates that 43% of the top-selling formula brands are out of stock. (31), The company representative added that theyre checking if they could tap into the Nestle global nutrition network for other formulas they could import after the FDA announced that companies are given temporary flexibility for importing baby formulas to address the shortage. 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. Symptoms of a Cronobacter infection include poor feeding, jaundice and grunting breaths, according to the FDA. 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. (1)(2), Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. Safety Alerts, Ready-to-feed liquid products for infants and children, An official website of the United States government, : Bing Guan/Reuters Overview Searching for a milk formula for your little one, but unsure which one to pick? They established an IMG (Incident Management Group) to continue working on these supply chain and food safety issues as the out-of-stock rates soared to 43%. (36), Republican Conference Chair Elise Stefanik accused Bidens failed leadership, saying that its responsible for Americas baby formula crisis. Learn More. (56), The recall was based on an internal quality review. (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. Cronobacter infection can be deadly, especially to newborns. Liquid baby formula and all other products produced by Abbott Nutrition are not affected. (61), The contamination was attributed to a manufacturing problem, but no serious health problems were reported concerning this recall. Find the answers below. Additionally, as part of Abbott's quality processes, we conduct routine testing forCronobacter sakazakiiand other pathogensin our manufacturing facilities. (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. This investigation is ongoing. Similac and other formulas will be next in line once production starts. Top FDA Official Resigns Over Formula Shortage, Abbott Under Criminal Investigation Over Possible Role In Baby Formula Shortage, Enfamil Maker Believes Shortage Will Last Until Spring, FDA Plans To Allow Overseas Formulas Beyond Shortage, FDA Investigates Another Abbott Formula-related Baby Death, Newly Reopened Abbott Plant Shuts Again Due To Floods, After President Joe Biden announced Operation Fly Formula, several shipments have arrived from across the world to help the US solve the, 95,000 cans arrived in LAX for Walmart, Albertsons Companies, and The Kroger Company grocery stores from Australia. (57), This voluntary recall included up to 5 million Similac powder infant formula units in plastic containers and 8-ounce, 12.4-ounce, or 12.9-ounce cans sold in the US, Guam, Puerto Rico, and some Caribbean countries. Importantly, no distributed product has tested positive for the presence ofCronobacter sakazakii. Prevent fake or fraudulent products from reaching store shelves. (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. I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. (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. Their first shipment will be Aptamil First Infant Milk Stage 1 (formula for healthy babies). powder . But it poses no immediate health risk of food poisoning. If you still wish to opt-out, please click the button below to confirm. Follow the directions in the email to reset your password. Similac issued three recall notices in 2022, involving multiple formula products. The White House recently announced Operation Fly Formulas tenth flight to Fort Worth, Texas from Mexico, which will bring approximately 1 million pounds (equivalent to around 16 million 8-oz bottles) of Gerber Good Start Gentle infant formula. Similac Formula Recall Washington WIC - Temporary Choices for Infant Formula November 1 , 2022 1 Similac Formula Recall - November 1, 2022 . Our formula also has nutrition designed for immune support, brain development, and digestive health. (21), The first two Defense Production Act authorizations are priority orders for Reckitt Benckiser (Mead-Johnsons Enfamil) and Abbott Nutrition: (31), Once the Abbott plant resumes operations, these priority shipments are expected to help increase their production by one-third. 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. The Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. We want to extend our heartfelt sympathies to the family. 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. But something must be done to correct this serious safety concern. Some of these facility improvements include the following: (44), US President Joe Biden met with infant formula manufacturers and retailers, including Reckitt, Gerber, Walmart, and Target, to discuss strategies to get more formula quickly yet safely onto store shelves to solve the ongoing shortage. Additionally, as part of Abbotts quality processes, we conduct routine testing for Cronobacter sakazakii and other pathogensin our manufacturing facilities. (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. Why did the FDA not spring into action? The recall was issued following consumer reports of four babies hospitalized, and one possible death due to Cronobacter. It also does not include any amino acid-based formulas or metabolic nutrition formulas. The company announced that it will prioritize EleCare production as well as other specialty and metabolic formulas for babies with severe food allergies and digestive problems. Similac is among the most popular formula brands, but is it a healthy option for your baby? Affected customers were advised to search for the lot number of their item at similac.com/recall. (2). First European Shipment Arrives In The US, House Passes $28 Million Emergency Spending & WIC Flexibility Bills. (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. Many parents also consider the following European formulas as the best organic options for their babies: Please consult your healthcare provider before switching to these formulas. (28), However, Abbott denies that the buyback program hurt their products safety. Jaundice (yellow skin and whites of the eyes). (41)(42). After the recall, however, they had to try other formula options but were unable to tolerate them, leading to dehydration. (55), The formula is safe to consume, but incorrect preparation using the provided scoop might not provide enough nutrients for your babys normal growth. (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. . The shipment included 132 pallets of both the Nestle Health Science Alfamino Infant and the Alfamino Junior formulas. (30), She further explained that its important to solve the problem as soon as possible. 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. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. (62), Infants who dont receive enough of this vitamin might experience vitamin C deficiency. And the retained sample related to the complaint forSalmonellaNewport tested negative forSalmonella. Why did it take four months to pull this formula off store shelves? Symptoms may include irritability with generalized tenderness. (56), It affected products made at a plant in Sturgis, Michigan. Abbott said it would restart EleCare production, upon reopening, followed by specialty and metabolic formulas. It can even lead to an imbalance in your babys body that might cause their heart to stop. The site is secure. Alternatives To Similac & Other Recalled Baby Formulas, *Check out our interviews with Serenity Kids founders on their. (28), American Economic Liberties Project senior fellow Moe Tkacik accused companies like Abbott of using their products as a personal ATM. Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage in the US. The company assures consumers that they have improved their protocols and systems at the facility. All finished products are tested for Cronobacter sakazakii, Salmonella Newport and other pathogens and they must test negative before any product is released. because of recent Congressional Reports showing that many popular manufacturers are selling products tainted with high levels of toxic heavy metals. You can find more information about these recalls below. Affected lots (same bottle and case numbers): Bottle lot numbers only (no case lot numbers provided): Abbott Nutrition clarifies that the recall only affects these products and specific lot or case/carton numbers. (56), The formula has a much lower iron content than the concentration indicated on the label. (44), According to Abbott Nutrition, theyll prioritize producing Alimentum, EleCare, and metabolic formulas. 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