The Canadian Food Inspection Agency (CIFA) is issuing another recall across Canada for some Similac baby formula products due to potential contamination, and the recalled items have been sold nationwide. oz/59 ml ready-to-feed products: U.S. - certain lots of Similac 360 Total Care, Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Pro-Total Comfort . (56), It affected products made at a plant in Sturgis, Michigan. However, theyre still running out of formulas. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. Before the massive Similac recall, Abbott Nutrition topped the market spot with 40% of the market share, closely followed by the long-time number 2 player in the US, Enfamil. It was the facility shut down in February following the massive Similac recall. 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%. The doctor explained that these kids didnt have other illnesses and could have stayed at home. Similac and other formulas will be next in line once production starts. (32), The products originated from Zurich, Switzerland, and were trucked to Germany. Why it matters: About 3 in 4 babies are fed formula by six months old as a complete or partial substitute for human milk, Axios' Nathan Bomey reports. (32), Another one was hospitalized due to mineral imbalances after their caregiver mixed their own formula. They also need to promptly notify the FDA about the situation. It will take around three weeks or June 20 before these formulas will hit market shelves. (1)(2), Parents are advised to check the packaging of their Similac powdered formulas. This database includes recalls from Health Canada, the Canadian Food Inspection Agency, and Transport Canada. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. (44), According to Abbott Nutrition, theyll prioritize producing Alimentum, EleCare, and metabolic formulas. Congressional leaders and various groups also want to hold the FDA accountable for whatever lapses or responsibilities it might have overlooked that led to the Abbott plant closure and baby formula shortage. (11), According to the FDA, the infant death reportedly happened in January. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. (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. (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. (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. (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. It may also cause bowel damage and can spread through the blood to other parts of the body. The .gov means its official.Federal government websites often end in .gov or .mil. (29), Wyden has reportedly requested Abbott for more information regarding their stock buyback program. that first started with supply chain issues. (34), They have also increased production and worked round the clock to help meet the demand. Infant Formula Supply, Recent Recalled Product Photos on FDA's Flickr Photostream. (37), Currently, 90% of the US formula market is dominated by just four players: (37), These four companies also dominate the federal contracts for the WIC program for low-income families, which accounts for 50% of US formula productions. According to the recall advisory, products from Abbott Nutritions Sturgis, Michigan facility have been distributed across the US and likely to have been exported to other countries. The CDC (Centers for Disease Control and Prevention) announced on May 12, 2022, that it had closed the Abbott Nutrition investigation that linked the formula manufacturer to deadly Cronobacter infections. They believe that having a leader in this position can unify and improve the FDAs food program. (47). (1). Why it matters: About 3 in 4 babies are fed formula by six months old as a complete or partial substitute for human milk, Axios' Nathan Bomey reports. Then, ready-to-feed liquid products (product names listed below) were recalled in October over a manufacturing that might cause spoilage. 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 . (30), She further explained that its important to solve the problem as soon as possible. There isnt any recent Parents Choice formula recall (only a Walmart pull-out of Parents Choice wipes). (53), Also, some of the formulas have low iron levels that didnt meet the minimum of 1 mg iron per 100 calories. (40). (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. Double-check the full product name, lot code, batch number, and the expiration or use by date. However, the baby formula shortage from supply chain issues and the Similac recalls reduced the available products. (44). 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. It was especially more difficult for children who need specialty formulas that were only manufactured by Abbott. 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. 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. We found no evidence ofSalmonellaNewport. 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. Theyre now investigating the circumstances of the babys death. (50), The company insists that despite their products being the center of the issue, their investigations showed these arent the source of the infections. 2 fl oz ready-to-feed liquid products included in this voluntary recall: Its important to note that not all recalled products were distributed in all countries and not all 2 fl oz/59 ml formulas are included in the recall. (36), A total of 192 Republican lawmakers voted against the bill, claiming that throwing millions of dollars at the problem wont fix it. (36), The Houses budget measure is expected to meet more resistance in the Senate. (18), None of the DNA sequences in the FDA investigation matched the companys products. (Liquid Ready-To-Drink Formula), The bottles had a missing special layer that keeps air out. (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. (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. (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. (5)(45), The White House explains that manufacturers typically produce the same formula type in various package sizes to meet the demand. . Jaundice (yellow skin and whites of the eyes). The baby reportedly consumed formula made by Abbott Nutrition. These were loaded on one C-17 cargo plane at Ramstein Air Base in Germany and flown to Indianapolis. 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. 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. The recalled products have been sold across the country. (2). Similac 360 Total Care Sensitive 30.2 oz. The case remains under investigation, with authorities still trying to determine the cause of the infants, Abbott clarifies that no distributed product (Similac PM 60/40 or the previously recalled Similac, Alimentum, and EleCare powdered infant formulas) tested positive for the presence of, Tests of retained product samples from the recalled Similac PM 60/40 lot were negative for, Similac Recall February 2022 (First Recall), Similac recalls several powdered formulas for possible contamination that can cause, infection. (1), Affected bottle and carton or case lot numbers in the US: (1), Affected lots with the same bottle and case numbers: (1), Bottle lot numbers only (no case lot numbers provided): (1), Carton or case lot numbers only (no bottle lot numbers provided): (1). powder . Why did the FDA not spring into action? 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. We found no evidence of Salmonella Newport. 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. Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. (37). Additionally,recently tested retained product samples of Similac PM 60/40 Lot # 27032K80 (can) / Lot #27032K800 (case) were negative forCronobacter. 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. Additionally, retained samples related to the three complaints forCronobacter sakazakiitested negative forCronobacter. One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. (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. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. (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. Why did the FDA not spring into action? If your product is affected by this recall, dont use it even if it looks alright. (7). Yes. Key ingredients found in breast milk including 5 HMO prebiotics. because of recent Congressional Reports showing that many popular manufacturers are selling products tainted with high levels of toxic heavy metals. Click Here for Recall Information: 2 fl oz Ready-to-Feed Liquid Recall (Oct 2022) or Powder Formula Recall (Feb 2022). (61), Similac Special Care Ready-to-Feed Premature Infant Formula Powder with Iron (2-ounce bottles), Is There A Recall On Similac Alimentum? For all feeding-related questions or questions about your childs health, contact a healthcare professional. Abbott Nutrition, which makes the Similac, Alimentum and EleCare brands, on Thursday issued a voluntary recall of certain formulas manufactured at its plant in Sturgis, Mich., where the formulas involved in the infections were produced. Two recalled Similac products were sold between November 1, 2020, and February 17, 2022:. (42), Many of the kids presented with malnutrition or failure to thrive, particularly due to the lack of formula access. Although the formula shortage began in 2021, Abbotts massive recall worsened the problem. She encourages parents and caregivers to ask their pediatrician before giving any kind of formula substitute to their babies. 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. (7), When Abbott shut down from February to June 2022, it worsened the already existing formula shortage. 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. However, she warned that formula dilution can lead to organ failure or brain swelling. (31), This next shipment from Ramstein Air Base is expected to land in Pennsylvania for distribution by the Nestle facility in the area. (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. However, the recall and Abbotts plant closure elevated Enfamil to the top spot with 50% of the market share, Reckitt Benckiser claims. Priority will be given to worst-hit regions, a Biden administration official said. "We value the trust parents place in us for high quality and safe nutrition," Abbott said in a statement provided to NPR. Yes, but: Lot numbers of the affected products are listed at Similacrecall.com. 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. According to the hospital spokesperson, the kids ranged from babies to older children. This is subject to the FDAs approval. But something must be done to correct this serious safety concern. (12), These flights will arrive starting on June 24. 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. (55), Batch no. Democrats also proposed a $28 million emergency spending bill to supposedly boost the FDAs resources, including adding more staff. ", What's next: The company said it 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. (21), Rep. Andy Harris, chair of the Appropriations subcommittee that funds the FDA, claimed that it wasnt a money problem but a leadership issue. The one fatal case has not been confirmed to be solely related to a Cronobacter infection, according to the FDA. (34), According to a Nestle representative, these products serve a critical medical purpose because theyre for babies with cows milk protein allergies. Learn More. If a product is included in the recall,do not use the product. (45), According to the White House fact sheet, some unscrupulous retailers or individuals used the formula shortage to hoard products from legitimate suppliers. 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 , which shouldnt have been sold back to consumers at all. At least two kids have been hospitalized in direct connection with the formula shortage. After President Joe Biden announced Operation Fly Formula, several shipments have arrived from across the world to help the US solve the formula shortage. (6), In response, deputy commissioner Frank Yiannas of the FDAs Office of Food Policy and Response submitted his resignation, effective February 24. Abbott also reminds parents and caregivers that Cronobacter sakazakii can be commonly found in the environment and a variety of areas around the home. 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. Find the answers below. This recall was done after the death of another infant who tested positive for Cronobacter sakazakii. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. Contact 1800-10-995-1555 (Province), (02) 995-1555 (Manila), or, Several powdered baby formula products were recalled due to the remote possibility of contamination with larvae, full-grown adults, or insect parts of the small common beetle. (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. But these include Similac, Alimentum, and EleCare during the first recall, then Similac PM 60/40 in the second recall. 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