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. 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 Comfort TM, Similac 360 Total Care , Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Stage 1, Similac NeoSure , (62), Possible contamination with black polyvinyl chloride plastic particles (61), Similac Advance with Iron Formula Powder (12.9-ounce cans). (56), The formula has a much lower iron content than the concentration indicated on the label. Childrens Wisconsin warns that homemade formula can cause liver and/or kidney damage. One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. (41)(42). (28), However, Abbott denies that the buyback program hurt their products safety. The FDA had actually conducted plant inspections in September. A company spokesperson explained that their strong balance sheet allowed them to invest in improving their facilities even with the stock buybacks. 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. It was especially more difficult for children who need specialty formulas that were only manufactured by Abbott. Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. (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. The other reports were made from Ohio and Texas in the following months. It may also cause bowel damage and can spread through the blood to other parts of the body. (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. The FDA said environmental samples from the facility have yielded positive results for the Cronobacter bacteria, but there have been no reports of salmonella so far. (34), The FDA is also planning to update its review process for more foreign manufacturers to ship more formula products to the US and boost imports. All finished products are tested for Cronobacter sakazakii, Salmonella Newport and other pathogens and they must test negative before any product is released. Oz./59 mL Bottles of Ready-to-Feed Liquid Products; Recall Is Not Expected to Impact U.S. (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. Heres Everything You Need To Know, Nutricia Formula Wasnt Recalled in 2022, However It Did Test Positive For Cronobacter. The FDA clarifies that the recall is still in effect even though the investigation is closed. Symptoms may include irritability with generalized tenderness. 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. The doctor explained that these kids didnt have other illnesses and could have stayed at home. Cronobacter infection can be deadly, especially to newborns. To find out if the product you have is included in this recall, click on the button below to check your lot number. (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. However, the baby formula shortage from supply chain issues and the Similac recalls reduced the available products. (56), The recall was based on an internal quality review. 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. (1)(2), Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. This recall equates to less than one day's worth of the total number of ounces of infant formula fed in the U.S. and is not expected to impact the overall U.S. infant formula supply. The following formulas havent been recalled: Always make sure to check with your babys pediatrician before starting or switching formulas. 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. (44). This manufacturing defect may cause a decrease in the formulas vitamin C content over time. We found no evidence of Salmonella Newport. This voluntary recall only affected products sold in the Philippines. (21), Under this act, suppliers must prioritize orders from infant formula manufacturers before any of their other customers who may have ordered the same goods. This investigation is ongoing. (1). The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. (37). (12), These flights will arrive starting on June 24. Infant Formula Supply, Recent Recalled Product Photos on FDA's Flickr Photostream. (Liquid Ready-To-Drink Formula), The bottles had a missing special layer that keeps air out. According to Abbott, it will also resume the production of Similac and other formulas as soon as possible. Call Similac for refund processing or product replacement. At least two kids have been hospitalized in direct connection with the formula shortage. 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. because of recent Congressional Reports showing that many popular manufacturers are selling products tainted with high levels of toxic heavy metals. If you have questions, please contact Abbott's Consumer Relations hotlines below in the country where you received product: Join Similac Rewards for up to $400*in benefits and support throughout your journey. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. 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 company clarified that these products are only available in limited quantities because production hasnt resumed at the Sturgis facility. Abbott Recall | Powder Infant Formulas & 2 fl oz Ready-to-Feed Liquid Products, US - certain lots of Similac 360 Total Care, Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Pro-Total Comfort, Similac NeoSure, Pedialyte Electrolyte Solution, Canada - 1 lot of Pedalyte Electrolyte Solution; 1 lot of Similac Water (Sterilized), Puerto Rico, Bermuda, Curacao, Trinidad & Tobago, Jamaica - 1 lot of Similac 360 Total Care Sensitive, Puerto Rico, Curacao, Trinidad & Tobago, Barbados, Haiti, St. Thomas, St. Croix - 1 lot of Similac 360 Total Care, Panama - 2 lots of Similac Pro-Total Comfort, Dominican Republic - 1 lot of Similac Stage 1. Aside from checking the nutritional values and ingredients, its also a good idea to monitor for infant formula product recalls. Priority will be given to worst-hit regions, a Biden administration official said. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. (45), Abbott Nutrition recently announced that theyre releasing some metabolic nutrition and specialty formulas amid the infant formula shortage. (42). (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. The site is secure. While Abbott's testing of distributed product detected no pathogens, we are taking action by recalling the powder formula manufactured in this facility with an expiration of April 1, 2022, or later. 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. This is in addition to lots of Similac, Alimentumand EleCarepowder formula that were voluntarily recalled on Feb. 17. After President Joe Biden announced Operation Fly Formula, several shipments have arrived from across the world to help the US solve the formula shortage. 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. (42). (55), The formula is safe to consume, but incorrect preparation using the provided scoop might not provide enough nutrients for your babys normal growth. (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. (58), Abbott Laboratories Inc. assured affected customers that their tests showed only 0.16% of the recalled Similac products were contaminated. (1), The company explained that some of the bottles in the recalled lots might have bottle caps that were possibly not sealed completely. (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. bacteria, which caused serious infections. But with so many options available, even from the same brand, finding the right formula for your baby can be a huge challenge for many parents. There wasnt any connection between their products and the four reported illnesses. Similac 360 Total Care * Infant Formula is made with an exclusive blend of 5 HMO prebiotics structurally identical to those in breast milk. 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. (32), The products originated from Zurich, Switzerland, and were trucked to Germany. Abbott has informed the FDA of this new setback and announced that formula production will likely be delayed for a few weeks. Moms may have different reasons for choosing a particular formula for their babies. Instead, these products were those put on hold amid the recall. (32), Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage in the US. 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. (29). The one fatal case has not been confirmed to be solely related to a Cronobacter infection, according to the FDA. Between the lines: Abbott said the 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. 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 All finished infant formula powder products are tested forCronobacter,Salmonella,and other pathogens, and they must test negative before the product is released. 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. (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 shipment included 132 pallets of both the Nestle Health Science Alfamino Infant and the Alfamino Junior formulas. 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. (1) Is Similac formula good for babies? 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, theyre marking these up for online retail at exorbitant prices. "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. The recalled products have been sold across the country. This means you will no longer receive SMS notifications regarding Similac rewards or special offers. Recalls. 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. 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. (1). . (31), However, these specialty formulas arent expected to hit retail store shelves. Similac issued three recall notices in 2022, involving multiple formula products. Rakeen Mabud, the groups chief economist, pointed out that instead of improving its plant and making productive investments, Abbott chose to prioritize its shareholders. More are expected to arrive on three more flights in the coming weeks. Bing Guan/Reuters This case is under investigation, and at this time the cause of the infantsCronobacter sakazakiiinfection has not been determined. Why did it take four months to pull this formula off store shelves? This recall was done after the death of another infant who tested positive for Cronobacter sakazakii. Two recalled Similac products were sold between November 1, 2020, and February 17, 2022:. Key ingredients found in breast milk including 5 HMO prebiotics. When you buy through links on our site we may earn an affiliate commission. Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. Many parents are closely monitoring infant formula and. Latest News: Voluntary Recall of 2 fl oz Ready-to-Feed Liquid Products, U.S.: +1-800-986-8540, Puerto Rico: +1-787-622-5454, Barbados: 246-417-0777, Bermuda: 279-5568, Canada: 1-855-733-4201, Colombia: 1-800-518-9379, Curacao: 737-2222 Ext. On February 18, the Canadian Food Inspection Agency (CFIA) issued a recall for certain Abbott brand Similac powdered . 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. "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. Once they get the FDAs go-signal, Abbott will return to EleCare production before restarting Similac and other formula lines. Find the answers below. (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. (41), A spokesperson for the hospital refused to disclose the exact number of hospitalized kids but said that all had specific dietary needs. 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. Amid the formula shortage following the massive Similac recall earlier this year, many parents continue to face challenges in finding products for their children. (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. However, she warned that formula dilution can lead to organ failure or brain swelling. ". (32). If a product is included in the recall,do not use the product. If yes, what happened, and which products were included? He admitted to reading the complaint but didnt specify when or what steps he took to immediately address the issue. (30), To directly address the formula shortage, Biden invoked the Defense Production Act on May 18, 2022. (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. (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. Some of the hospitalized kids suffered malnutrition after taking homemade formula or other inappropriate substitutions. (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. (46), President Biden asked the FTC (Federal Trade Commission) to investigate and monitor the perpetrators of this illegal and predatory conduct. If a product is included in the recall, do not use the product. 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.
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