Federal inspectors found several safety violations: Some employees failed to sanitize their hands. (37), During the May 2022 hearing, FDA Commissioner Califf and lawmakers agreed that consolidation (strong market players taking over smaller competitions) made the US formula market more vulnerable to disruptions. This case is under investigation, and at this time the cause of the infantsCronobacter sakazakiiinfection has not been determined. Califf announced, instead, that Abbott could restart production in a week or two, pending safety upgrades and certifications. These were loaded on one C-17 cargo plane at Ramstein Air Base in Germany and flown to Indianapolis. The Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. (2). Why did the FDA not spring into action? (45), According to the White House fact sheet, some unscrupulous retailers or individuals used the formula shortage to hoard products from legitimate suppliers. Liquid baby formula and all other products produced by Abbott Nutrition are not affected. 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. 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. The recall was issued following consumer reports of four babies hospitalized, and one possible death due to Cronobacter. 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. (37). (59), 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. 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 Now you can switch to digital savings by phone on your favorite formulasheres how: Thanks, but I'll stick with paper for now. The baby had consumed Similac PM 60/40 from this lot. FDA Commissioner Dr. Robert Califf is the first administration official to face Congress in an investigation of the baby formula shortage. This recall doesnt include any metabolic deficiency nutrition formulas, Abbott liquid formulas, or other nutrition products. Food safety advocates are furious over how the FDA and Abbott handled these safety issues, especially because their lapses may have caused the death of at least two babies. The FDA requires formula manufacturers to meet this requirement to help prevent iron deficiency anemia, a condition that can lead to irreversible functional development outcomes. (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). Recalled: Similac Formulas Manufacturer's Recall Notice FDA Recall Notice sold at: Target Stores and Target.com recall date: 2/17/2022 Recall Description For more specific information regarding this recall, visit the government agency or manufacturer website: Product Recall Details Target Item Number: 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 , Abbott said it would restart EleCare production, upon reopening, followed by specialty and metabolic formulas. She encourages parents and caregivers to ask their pediatrician before giving any kind of formula substitute to their babies. And the retained sample related to the complaint forSalmonellaNewport tested negative forSalmonella. "We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need.". (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. Abbott Recalls Ready-to-Feed Liquid Products, 39480N200; 420395E00 (also distributed in Puerto Rico, Trinidad & Tobago, Curacao, Barbados, St Thomas, St Croix, and Haiti), 40561N200 (also sold in Puerto Rico, Curacao, Jamaica, Bermuda, and Trinidad & Tobago), 40749N200 sold in the Dominican Republic, 39398N200 (bottle lot number only) sold in Canada, Similac Recall February 2022 (Second Recall), This recall was done after the death of another infant who tested positive for. Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. 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. Two recalled Similac products were sold between November 1, 2020, and February 17, 2022:. Abbott also reminds parents and caregivers that Cronobacter sakazakii can be commonly found in the environment and a variety of areas around the home. According to the hospital spokesperson, the kids ranged from babies to older children. Bing Guan/Reuters (28), This alarmed progressive economic advocacy group, Groundwork Collaborative. (61), The contamination was attributed to a manufacturing problem, but no serious health problems were reported concerning this recall. In response, Abbott reportedly told the committee that the first report came in September from Minnesota health officials. But something must be done to correct this serious safety concern. If you have questions, please contact Abbott's Consumer Relations hotlines below in the country where you received product: More Recalls, Market (47), Abbott explains that the nutrition formulas will be released free of charge to patients but on a case-by-case basis and in coordination with healthcare professionals. Theyre now investigating the circumstances of the babys death. (1). Theyre currently working with the FDA to implement corrective actions at the plant before they can resume production. 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. To find out if the product you have is included in this recall, click on the button below to check your lot number. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. (37). If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. . Call Similac for refund processing or product replacement. that first started with supply chain issues. 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. (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. It may also cause bowel damage and can spread through the blood to other parts of the body. In several parts of the US, several babies and even older children have been hospitalized amid the formula shortage. (31), However, these specialty formulas arent expected to hit retail store shelves. 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. Directions apply to Chrome onAndroid devices. (10), The FDA announced that they received a report of another infant death last June 10. 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. The case remains under investigation, with authorities still trying to determine the cause of the infants Cronobacter sakazakii infection. (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. Surprisingly, however, the FDA didnt issue a safety notice nor did they stop Abbott from producing formulas until the issues have been resolved. (26), He explained that none of the data matched between the specimen from the four complaints and of the retained product samples. According to Abbott, it will also resume the production of Similac and other formulas as soon as possible. Some might feel more secure choosing a well-known brand name. For all feeding-related questions or questions about your childs health, contact a healthcare professional. However, issuing the voluntary recall was the right thing to do because they didnt want to risk the childrens lives and health. (28), Two years before the recall, Abbotts net profits increased from $3.6 billion to $7.1 billion, according to Securities and Exchange Commission records. Amid the formula shortage following the massive Similac recall earlier this year, many parents continue to face challenges in finding products for their children. (50), The company insists that despite their products being the center of the issue, their investigations showed these arent the source of the infections. We want to extend our heartfelt sympathies to the family. 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. (7). It was easier to increase the shipments because both were already being imported even before the shortage. They can also find it from the list that the company later released. Similac 360 Total Care * Infant Formula is made with an exclusive blend of 5 HMO prebiotics structurally identical to those in breast milk. "We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need.". (18), None of the DNA sequences in the FDA investigation matched the companys products. 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. Click on the "Learn More" button to see lot numbers included in the recall or scroll down to Check Lot Number. (62), Lot codes 40177RH and 40172RH, with a use by date of Nov. 1, 2007, The bottles lack a special layer that keeps air out. Many formulas from name brands like Similac are designed to closely resemble breast milk. The massive recalls worsened the formula shortage in the US that first started with supply chain issues. (20), Bubs Australia at least 1.25 million cans of baby formula (22), UK manufacturer Kendal Nutricare (makers of Kendamil) around 100 trucks over the next six months (23), Abbott Needs To Comply With Court Consent Decree Before Production Can Resume, Hiring an independent third party expert who will review its processes, Cleaning and sanitizing the entire facility, including all equipment, Restarting all the equipment and completing test runs, Conducting multiple tests of all equipment, Abbotts Serious Steps To Address The Formula Shortage, Creating a $5 million fund for children hospitalized due to lack of access to specialized products, Converting production lines at their Columbus, Ohio, facility to prioritize the production of ready-to-feed liquid infant formula, Air-shipping millions of widely used powdered baby formulas from an FDA-approved plant in Ireland to the US, More than double the current production to help produce more products to address the shortage, Make significant investments to improve facilities to ensure the issue doesnt happen again, Invest in upgrading safety and quality processes and equipment, FDA Refutes Abbotts Claim Regarding Bacterial Strains, Groups Claim Abbott Enriched Shareholders While Plant Needed Repairs, Pelosi Eyes Criminal Charges Over Baby Formula Shortage, For Abbott Nutrition raw materials like sugar and corn syrup for infant formula, For Reckitt filters and other single-use products to generate certain oils needed in their infant formula production, Formula Makers Import European Stocks To Help With US Shortage. (6), He explained that he inherited the decentralized structure of the foods program, which kept his office from functioning as an integrated team and subsequently protecting the public. Key ingredients found in breast milk including 5 HMO prebiotics. However, Califf reportedly sidestepped these questions by saying that he cant share details of the agencys ongoing investigation. Why did the FDA not spring into action? Safety Alerts, Ready-to-feed liquid products for infants and children, An official website of the United States government, : (16), Recalled Baby Formula Accidentally Sold In Canada, The first two digits are numbers from 22 to 37, The expiration date code starts from 4-1-2022 (APR 2022) and subsequent dates. (33), Formula makers quickly responded, with Nestle importing Alfamino from Switzerland and also Gerber Good Start Extensive HA from the Netherlands. The company clarified that these products are only available in limited quantities because production hasnt resumed at the Sturgis facility. (24)(25), These are some of the steps they need to comply with: (24)(25), The company must also review and change the following: (24), If any contamination is detected, Abbott is required to immediately stop production. (43). (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. These two shipments of Bubs amounted to 380,000 lbs equivalent to approximately 4 million eight-ounce bottles. Any changes to their formula need to be carefully monitored to make sure they could be well tolerated. (28). Have there been any formula recalls? Formulas still to arrive starting in June or July: The CFIA (Canadian Food Inspection Agency) warned consumers who bought from Shoppers Drug Mart to check their products after the retail pharmacy giant accidentally sold recalled baby formulas from Abbott due to an online error. (17). The following formulas havent been recalled: Always make sure to check with your babys pediatrician before starting or switching formulas. 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. (31), The White House further announced that the first round of flights will carry a total amount of formula equivalent to 1.5 million doses of eight-ounce bottles. They havent confirmed how many formula units have been recalled. (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. You can check if your powdered formula is affected by inspecting the code printed near the expiration date. (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. (58), Abbott Laboratories Inc. assured affected customers that their tests showed only 0.16% of the recalled Similac products were contaminated. However, all these infants were fed Abbott powdered formulas: (18), Abbott Nutrition finally restarted its facility in Sturgis, Michigan, on June 4, 2022. Rakeen Mabud, the groups chief economist, pointed out that instead of improving its plant and making productive investments, Abbott chose to prioritize its shareholders. hide caption. Aside from these two children, at least three babies have been hospitalized at the Medical University of South Carolina Shawn Jenkins Childrens Hospital in Charleston, South Carolina, due to intolerance after their parents or caregivers tried other formulas due to the shortage. Reckitt facilities can also operate at their maximum capacity following these shipments. (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. Consolidation Makes Formula Market Vulnerable, Reckitt Benckiser (Mead-Johnsons Enfamil), Making Food Safety A Priority To Avoid Repeat Of Formula Crisis, Babies Hospitalized Due To Formula Shortage, Two Children Hospitalized Because Their Specialty Formula Is Out Of Stock, Babies Hospitalized For Intolerance To New Formula & Mineral Imbalances, Undisclosed Number Of Children Hospitalized in Georgia, Undisclosed Number Of Kids Hospitalized in Wisconsin, Abbott Nutrition To Reopen Sturgis Plant Involved In Recall, According to Abbott Nutrition, theyll prioritize producing, and other formulas will be next in line once production starts. It isnt ideal for premature infants or those with digestive and metabolic issues. FDA does not endorse either the product or the company. (31). The following are some of the baby formulas recalled in 2021: These are imported products from Europe distributed by the online retail store LittleBundle website starting May 20, 2021. Affected customers were advised to search for the lot number of their item at similac.com/recall. (41)(42). The recall does not include any metabolic deficiency nutrition formulas. (14)(15), 200,000 8-ounce bottles of Kendamil formulas arrived at Dulles International Airport in Virginia from the United Kingdom. It is therefore important to verify the product lot number on the bottom or the side of the bottle. (42). Aside from checking the nutritional values and ingredients, its also a good idea to monitor for infant formula product recalls. 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. Similac is among the most popular formula brands, but is it a healthy option for your baby? Click Here for Recall Information: 2 fl oz Ready-to-Feed Liquid Recall (Oct 2022) or Powder Formula Recall (Feb 2022). One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. The FDA had actually conducted plant inspections in September. (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. Increase the shipments because both were already being imported even before the shortage and the retained sample related the... ( 15 ), the Houses budget measure is expected to hit retail store shelves something must be done correct. Of recalls, advisories, and at this time the cause of the.. To increase the shipments because both were already being imported even before the.. Important to verify the product lot number liquid baby formula shortage childs,! Remains under investigation, with authorities still trying to determine the cause of the bottle recalls! 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