Rakeen Mabud, the groups chief economist, pointed out that instead of improving its plant and making productive investments, Abbott chose to prioritize its shareholders. (49). Democrats also proposed a $28 million emergency spending bill to supposedly boost the FDAs resources, including adding more staff. Many parents are closely monitoring infant formula and baby food recalls because of recent Congressional Reports showing that many popular manufacturers are selling products tainted with high levels of toxic heavy metals. The baby reportedly consumed formula made by Abbott Nutrition. (61), The contamination was attributed to a manufacturing problem, but no serious health problems were reported concerning this recall. Abbott also reminds parents and caregivers that Cronobacter sakazakii can be commonly found in the environment and a variety of areas around the home. Dr. Mark Corkins, a pediatric gastroenterologist at Le Bonheur Childrens Hospital in Memphis, Tennessee, revealed that he admitted two patients because their specialty formula is out of stock. Any changes to their formula need to be carefully monitored to make sure they could be well tolerated. (31), However, these specialty formulas arent expected to hit retail store shelves. Yes. (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. 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. Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. 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. The recall does not include any metabolic deficiency nutrition formulas. Similac issued three recall notices in 2022, involving multiple formula products. 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. Importantly, no distributed product has tested positive for the presence ofCronobacter sakazakii. 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. Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. The shipment included 132 pallets of both the Nestle Health Science Alfamino Infant and the Alfamino Junior formulas. For all feeding-related questions or questions about your childs health, contact a healthcare professional. The US formula shortage 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. 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. 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. Recalled products can be identified by the 7 to 9 digit code and expiration date on. Abbott said it would restart EleCare production, upon reopening, followed by specialty and metabolic formulas. The following are affected by this recall: (2). Republicans are questioning why the FDA isnt held accountable for the shortage and the possible lapses that led to the deaths of the two babies linked to the Abbott products. Abbott has informed the FDA of this new setback and announced that formula production will likely be delayed for a few weeks. It also does not include any amino acid-based formulas or metabolic nutrition formulas. 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. I am equally concerned that the FDA reacted far too slowly to this report. So, its important to follow the instructions found on the packaging for proper preparation, handling, and storage of all powder formulas to avoid contamination. Califf announced, instead, that Abbott could restart production in a week or two, pending safety upgrades and certifications. Its unclear why that happened, but the FDA hasnt issued a statement regarding this possible judgment lapse. (27), According to Ford, none of the bacterial strains that caused the infection of four infants, killing two babies, were found in Abbotts products. If you have any of these products, dont feed them to your baby. Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. After President Joe Biden announced Operation Fly Formula, several shipments have arrived from across the world to help the US solve the formula shortage. (2). During a May 2022 bipartisan hearing, Rep. Rosa DeLauro and other lawmakers repeatedly asked the FDA head why the agency took several months to investigate a whistleblower complaint on safety violations at Abbotts plant. Recalls. (39). 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. (37). However, all these infants were fed Abbott powdered formulas: (18), Abbott Nutrition finally restarted its facility in Sturgis, Michigan, on June 4, 2022. (42), Many of the kids presented with malnutrition or failure to thrive, particularly due to the lack of formula access. (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. (34), They have also increased production and worked round the clock to help meet the demand. There wasnt any connection between their products and the four reported illnesses. (32), Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage in the US. Moms may have different reasons for choosing a particular formula for their babies. 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. (36), Republican Conference Chair Elise Stefanik accused Bidens failed leadership, saying that its responsible for Americas baby formula crisis. 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. For all feeding-related questions or questions about your childs health, contact a healthcare professional. 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. (45), The White House released the additional measures they will follow to increase the formula products available without compromising babies safety: (45), The US typically produces nearly all (around 98%) of the infant formulas it needs. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. (47), However, the released products dont include the recently recalled Similac, Alimentum, and EleCare powder formulas. iPhone users should open in Safari. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. 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. On February 18, the Canadian Food Inspection Agency (CFIA) issued a recall for certain Abbott brand Similac powdered . (53), Possible health risks due to incorrect labels (the product is not intended for use as infant formula) (54), Similac TummiCare One Infant Formula Recall (Philippines), Abbott recalled these products for differences in the preparation scoop size and the label instructions. (30), She further explained that its important to solve the problem as soon as possible. This recall was done after the death of another infant who tested positive for Cronobacter sakazakii. Childrens Wisconsin warns that homemade formula can cause liver and/or kidney damage. (28), House Speaker Nancy Pelosi said that there might be a need for indictment after the nationwide baby formula shortage is resolved. (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. 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. We want to extend our heartfelt sympathies to the family. Symptoms may include irritability with generalized tenderness. Call Similac for refund processing or product replacement. (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. (28), However, Abbott denies that the buyback program hurt their products safety. You can check if your powdered formula is affected by inspecting the code printed near the expiration date. (1). ". (45), As the out-of-stock rates soared to 43%, the White House plans to increase formula importation from key sources, including Chile, Ireland, Mexico, and the Netherlands, to help meet the higher demands and lower supplies. Affected customers were advised to search for the lot number of their item at similac.com/recall. 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. (41), A spokesperson for the hospital refused to disclose the exact number of hospitalized kids but said that all had specific dietary needs. (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. Some of the hospitalized kids suffered malnutrition after taking homemade formula or other inappropriate substitutions. 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. Oz./59 mL Bottles of Ready-to-Feed Liquid Products; Recall Is Not Expected to Impact U.S. 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. It was the facility shut down in February following the massive Similac recall. It was especially more difficult for children who need specialty formulas that were only manufactured by Abbott. You can find more information about these recalls below. 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. Double-check the full product name, lot code, batch number, and the expiration or use by date. It was also quickly approved by the Senate and is now up to Biden to sign into law. Abbott voluntarily recalled one lot of Similac PM 60/40 with lot #27032K80 (can) or lot # 27032K800 (case) also manufactured in the companys facility in Sturgis, Michigan. . Many European formulas arent approved by the FDA, although many parents still prefer them over US brands. (1), Babies can experience vomiting, diarrhea, and gastrointestinal symptoms if they consumed the spoiled products. Click on the "Learn More" button to see lot numbers included in the recall or scroll down to Check Lot Number. 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). But there were no serious medical complaints reported concerning this Similac recall. When you buy through links on our site we may earn an affiliate commission. Before sharing sensitive information, make sure you're on a federal government site. The recalled products have been sold across the country. (6), The US Justice Department, through its consumer protection branch, is reportedly conducting a criminal investigation over Abbotts possible role in the formula shortage. (7). All finished products are tested for Cronobacter sakazakii, Salmonella Newport and other pathogens and they must test negative before any product is released. The doctor explained that these kids didnt have other illnesses and could have stayed at home. (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. The company assures consumers that they have improved their protocols and systems at the facility. Heres Everything You Need To Know, Nutricia Formula Wasnt Recalled in 2022, However It Did Test Positive For Cronobacter. "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. Instead, theyll be distributed to pharmacies, hospitals, and doctors offices first. Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage in the US. (28), Then, the company allegedly increased its dividends by over 25% and offered shareholders a stock buyback program worth $5 billion. (42). As of May 8, 2022, market research company Datasembly estimates that 43% of the top-selling formula brands are out of stock. (9), The FDA plans on allowing the import of overseas formulas from temporary importers to go beyond the shortage in a bid to prevent it from happening again. (31). The first recall (Similac, Alimentum, and EleCare powdered infant formulas) was issued on February 17 due to possible contamination with Cronobacter sakazakii bacteria, which caused serious infections. It may cause a decrease in vitamin C levels over time. (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. (56), The recall was based on an internal quality review. (1) Is Similac formula good for babies? Still, parents are also having trouble finding these products for their babies. 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%. (32), Some children with complex medical issues have been hospitalized for malnutrition at the Childrens Healthcare of Atlanta in Georgia, with some admitted back in February after the Abbott plant was closed. The baby had consumed Similac PM 60/40 from this lot. (1), The company explained that some of the bottles in the recalled lots might have bottle caps that were possibly not sealed completely. (12), Just days after finally reopening since shutting down in February, Abbott Nutritions Sturgis plant closes again due to floods affecting the area. 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. The USDA (United States Department of Agriculture) is also coordinating with various states to let WIC recipients purchase whatever products are in stock instead of being limited to WIC-approved options. As of press time, Abbotts Sturgis plant remains closed. (40), They relied on the amino acids (building blocks of proteins) from EleCare for nourishment because these dont have to be digested. (53), These products are affected by the recall: (54), This infant formula recall included these Similac products: (57)(58), According to the FDA (U.S. Food and Drug Administration) recall notice, ingestion of the larvae or beetle could cause intestinal discomfort, and the child might refuse to eat. (1), According to the recall advisory, these are the affected products: (1), Abbott Nutrition clarified that only a small percentage of bottles might have been affected by the manufacturing defect. 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. Contains no artificial growth hormones and is non-GMO. Find the answers below. 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. (30), To directly address the formula shortage, Biden invoked the Defense Production Act on May 18, 2022. , which shouldnt have been sold back to consumers at all. More are expected to arrive on three more flights in the coming weeks. Similac 360 Total Care 32 oz Please be sure to carefully check the labels for the substitute formulas. powder . (37). Contact the store or manufacturer for the refund or replacement process. Crouse said that the exact number of children hospitalized relating to the formula shortage isnt available, but its apparent that theyve had several of these admissions. The FDA had actually conducted plant inspections in September. We found no evidence of Salmonella Newport. This voluntary recall only affected products sold in the Philippines. 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. ", 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. The following formulas havent been recalled: Always make sure to check with your babys pediatrician before starting or switching formulas. (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. Senate To Investigate Abbotts Safety Improvements & Buyback Program, The Senate Finance Committee recently announced through Senator Ron Wyden that theyre going to investigate Abbotts investments in their plants safety improvements amid record revenues. (26), However, he clarified that they wouldnt tolerate having bacteria in their plant, something that the FDA found during their investigation. 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. To find out if the product you have is included in this recall, click on the button below to check your lot number. Still, the experience pushed economists to call for bans on buybacks, stricter antitrust enforcement, and limits on shareholder dividends. (37). They also need to promptly notify the FDA about the situation. 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. There werent any new cases identified as part of the investigation. Liquid baby formula and all other products produced by Abbott Nutrition are not affected. If the product is part of the recall, immediately stop giving it to your child, especially recalled products with Salmonella and other pathogens. (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. First European Shipment Arrives In The US, House Passes $28 Million Emergency Spending & WIC Flexibility Bills. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. (12), These flights will arrive starting on June 24. (14)(15), 200,000 8-ounce bottles of Kendamil formulas arrived at Dulles International Airport in Virginia from the United Kingdom. (61). Previous investigations by the FDA (Food and Drug Administration) reportedly discovered several violations, including Abbotts lax safety protocols and bacterial contamination at its manufacturing facility. By opting-out, you are removing your phone number from your Similac profile. 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 . (40). Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. The massive recalls worsened the formula shortage in the US that first started with supply chain issues. If a product is included in the recall, do not use the product. Theyre now investigating the circumstances of the babys death. "We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need.". 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Has tested positive for Cronobacter sakazakii can be commonly found in the US Abbotts. As part of the possible indictment product is included in the US, House Passes $ 28 million emergency &... To the official website and that any information you provide is encrypted and transmitted.!
