(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. The one fatal case has not been confirmed to be solely related to a Cronobacter infection, according to the FDA. Federal inspectors found several safety violations: Some employees failed to sanitize their hands. (34), They have also increased production and worked round the clock to help meet the demand. 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. The recalled products have been sold across the country. The products included in the recall were manufactured at our Columbus, Ohio, manufacturing facility. The baby had consumed Similac PM 60/40 from this lot. (13), 750,000 cans of Danone formula, which is equivalent to 19 million 8-ounce bottles, will arrive from their manufacturing facility in Ireland in July. A company spokesperson explained that their strong balance sheet allowed them to invest in improving their facilities even with the stock buybacks. 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. The massive recalls worsened the formula shortage in the US that first started with supply chain issues. (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. When you buy through links on our site we may earn an affiliate commission. Many European formulas arent approved by the FDA, although many parents still prefer them over US brands. . Find the answers below. (21), Democrat Rep. Rosa DeLauro, the chair of the House Appropriations Committee, explained that this will increase the FDAs staff so more of them can do the following: (21), However, this bill has been met with resistance, with other lawmakers such as Rep. Bill Huizenga saying that more formula production is needed, not more FDA staff. To find out if the product you have is included in this recall, click on the button below to check your lot number. Around 50% of the market demand comes from the WIC program (Special Supplemental Nutrition Program for Women, Infants, and Children). 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. (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. Two recalled Similac products were sold between November 1, 2020, and February 17, 2022:. (56), It affected products made at a plant in Sturgis, Michigan. (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. (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. Symptoms may include irritability with generalized tenderness. 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. Then, ready-to-feed liquid products (product names listed below) were recalled in October over a manufacturing that might cause spoilage. 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. 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. Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. (1). Some of the companies that offered to help: A consent decree filed at the US District Court for the Western District of Michigan created a legally binding agreement between Abbott and the FDA, with steps that the company had to comply with before production at the Sturgis facility can resume. (33)(35), This is significant because the WIC program (Special Supplemental Nutrition Program for Women, Infants, and Children) accounts for as much as 50% of infant formula sales in the US. (13). They believe that having a leader in this position can unify and improve the FDAs food program. 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. (2). Moms may have different reasons for choosing a particular formula for their babies. 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 SimilacPro-Total ComfortTM, Similac360 Total Care, Similac 360 Total Care Sensitive, SimilacSpecial Care24, Similac Stage 1, SimilacNeoSure, Similac Water (Sterilized) and Pedialyte Electrolyte Solution. 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%. (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. Democrats also proposed a $28 million emergency spending bill to supposedly boost the FDAs resources, including adding more staff. However, Califf reportedly sidestepped these questions by saying that he cant share details of the agencys ongoing investigation. (34), According to a Nestle representative, these products serve a critical medical purpose because theyre for babies with cows milk protein allergies. Abbott also reminds parents and caregivers that Cronobacter sakazakii can be commonly found in the environment and a variety of areas around the home. This can result in spoilage. 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 . 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 recall does not include any metabolic deficiency nutrition formulas. (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. Childrens Wisconsin warns that homemade formula can cause liver and/or kidney damage. In several parts of the US, several babies and even older children have been hospitalized amid the formula shortage. 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. After the recall, however, they had to try other formula options but were unable to tolerate them, leading to dehydration. Theyre currently working with the FDA to implement corrective actions at the plant before they can resume production. . Foster a culture of compliance to ensure they produce the highest quality baby formulas, Empower workers to identify and report issues that could compromise their products safety and quality. After President Joe Biden announced Operation Fly Formula, several shipments have arrived from across the world to help the US solve the formula shortage. (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. 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. (4), Although the February 2022 Similac recall due to bacterial infections (discussed in detail below) is among the main causes of the formula shortage, authorities explained that supply chain issues and higher demands were already causing a shortage even in 2021. According to Abbott, it will also resume the production of Similac and other formulas as soon as possible. (1)(2), Parents are advised to check the packaging of their Similac powdered formulas. Click on the "Learn More" button to see lot numbers included in the recall or scroll down to Check Lot Number. I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. This recall was done after the death of another infant who tested positive for Cronobacter sakazakii. For all feeding-related questions or questions about your childs health, contact a healthcare professional. Still, the experience pushed economists to call for bans on buybacks, stricter antitrust enforcement, and limits on shareholder dividends. (55), The formula is safe to consume, but incorrect preparation using the provided scoop might not provide enough nutrients for your babys normal growth. Jaundice (yellow skin and whites of the eyes). Tests of retained product samples from the recalled Similac PM 60/40 lot were negative for Cronobacter. (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. If a product is included in the recall,do not use the product. It may cause a decrease in vitamin C levels over time. This voluntary recall only affected products sold in the Philippines. (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. (40), They relied on the amino acids (building blocks of proteins) from EleCare for nourishment because these dont have to be digested. (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. (30), She further explained that its important to solve the problem as soon as possible. The following formulas havent been recalled: Always make sure to check with your babys pediatrician before starting or switching formulas. 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. A review of Abbott's records show that the company has destroyed products in the past due to the presence of Cronobacter. Similac issued three recall notices in 2022, involving multiple formula products. (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. (1), ByHeart Whole Nutrition Infant Formula Recall, The Similac Recall & The Formula Shortage (2022), in the US, worried parents are having difficulty finding supplies for their babies. Yes, but: Lot numbers of the affected products are listed at Similacrecall.com. (26), Abbotts head detailed the serious steps the company is taking to address the baby formula shortage: (26), Once the production resumes at Sturgis, Michigan, Ford detailed that they will do the following: (26), While Abbott maintains that the strains from the FDAs investigations dont match those taken from their facility, FDA officials recently refuted this claim. (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. (32), Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage in the US. (37). (1). (4). 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. (18), None of the DNA sequences in the FDA investigation matched the companys products. (4), Thats why theres also a shortage in the store brands like. 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. powder . If the product is part of the recall, immediately stop giving it to your child, especially recalled products with Salmonella and other pathogens. 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 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. 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 Theyre also asking for answers to get to the bottom of the problem and to ensure that infant formula contaminations wouldnt happen again. From December 1, 2021, to March 3, 2022, the FDA reportedly received a total of nine reports of formula-related baby deaths, with two among the four confirmed Cronobacter sakazakii infections that led to the February 2022 Similac recall. 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. hide caption. 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. 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. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. However, she warned that formula dilution can lead to organ failure or brain swelling. Follow the directions in the email to reset your password. (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. Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. A thorough review of all available data indicates that the infant formula produced at our Sturgis facility is not likely the source of infection in the reported cases and that there was not an outbreak caused by products from the facility. They havent confirmed how many formula units have been recalled. Theyre now investigating the circumstances of the babys death. President Joe Biden had previously directed various agencies to import products from companies overseas that meet US standards using military planes through Operation Fly Formula. (21). 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 brandsSimilac Pro-Total Comfort, Similac360 Total Care, Similac360 Total CareSensitive, SimilacSpecial Care24, SimilacStage 1, SimilacWater (Sterilized), Similac NeoSure, and PedialyteElectrolyte Solution. Symptoms of a Cronobacter infection include poor feeding, jaundice and grunting breaths, according to the FDA. iPhone users should open in Safari. Many formulas from name brands like Similac are designed to closely resemble breast milk. Similac, by Abbott Laboratories, is one of the leading infant formula brands in the US. Instead, theyll be distributed to pharmacies, hospitals, and doctors offices first. Two House bills were passed to address the shortage. They havent confirmed how many formula units have been recalled. 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. 02.28.2022 UPDATE: Abbott is voluntarily recalling one lot of Similac PM 60/40 (Lot #27032K80 (can) / Lot # 27032K800 (case)) manufactured in Sturgis, Michigan. Federal inspectors found several safety violations: (43)(51)(52). With the ongoing infant milk formula shortage in the US, worried parents are having difficulty finding supplies for their babies. (55), Batch no. (21), Rep. Andy Harris, chair of the Appropriations subcommittee that funds the FDA, claimed that it wasnt a money problem but a leadership issue. Similac and other formulas will be next in line once production starts. (28), Then, the company allegedly increased its dividends by over 25% and offered shareholders a stock buyback program worth $5 billion. Many parents are closely monitoring infant formula and. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. (50), The company insists that despite their products being the center of the issue, their investigations showed these arent the source of the infections. Photo: Stefani Reynolds / AFP via Getty Images. (6), The US Justice Department, through its consumer protection branch, is reportedly conducting a criminal investigation over Abbotts possible role in the formula shortage. (47). 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 . 03518QU (manufacturing date March 2019; expiration date March 2022). All finished products are tested for Cronobacter sakazakii, Salmonella Newport and other pathogens and they must test negative before any product is released. As of press time, Abbotts Sturgis plant remains closed. (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. powdered infant formulas) was issued on February 17 due to possible contamination with. First European Shipment Arrives In The US, House Passes $28 Million Emergency Spending & WIC Flexibility Bills. (11). (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. Similac Formula Recall Washington WIC - Temporary Choices for Infant Formula November 1 , 2022 1 Similac Formula Recall - November 1, 2022 . (41), A spokesperson for the hospital refused to disclose the exact number of hospitalized kids but said that all had specific dietary needs. 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. (29). These two shipments of Bubs amounted to 380,000 lbs equivalent to approximately 4 million eight-ounce bottles. (31), This next shipment from Ramstein Air Base is expected to land in Pennsylvania for distribution by the Nestle facility in the area. And the retained sample related to the complaint forSalmonellaNewport tested negative forSalmonella. But something must be done to correct this serious safety concern. (27), According to Ford, none of the bacterial strains that caused the infection of four infants, killing two babies, were found in Abbotts products. After dismissal, the employee reportedly made the false allegations and submitted the false report to multiple authorities. (61), Similac Special Care Ready-to-Feed Premature Infant Formula Powder with Iron (2-ounce bottles), Is There A Recall On Similac Alimentum? Bing Guan/Reuters Why did it take four months to pull this formula off store shelves? 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: (12), These flights will arrive starting on June 24. Recalls. (13). (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. Retail companies like Walmart have already put a cap on how many you can buy per transaction. The doctor explained that these kids didnt have other illnesses and could have stayed at home. There werent any new cases identified as part of the investigation. Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. Why did it take four months to pull this formula off store shelves? The shipment was taken to the Nestle distribution center about a mile away for standard quality control checks. Importantly, no distributed product has tested positive for the presence ofCronobacter sakazakii. The FDA relaxed some regulations to make it easier for foreign companies to import formulas to the US, while also assuring parents that these products meet US standards. One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. If your infant is experiencing symptomsrelated toCronobacterorSalmonellainfection,such as poor feeding, irritability, temperature changes, jaundice, grunting breaths, abnormal movements, lethargy, rash, or blood in the urine or stool; contact your health care provider to report their symptoms and receive immediate care. 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. 83/ounce) Enfagrow Premium Powder Toddler Formula - 32oz . (13), The company needs to conduct comprehensive testing with an independent third party to determine if the plant is safe to reopen. During testing in our Sturgis, Mich., facility, we found evidence of Cronobacter sakazakii in the plant in non-product contact areas. 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. (45), Abbott Nutrition recently announced that theyre releasing some metabolic nutrition and specialty formulas amid the infant formula shortage. (20). (1). But it poses no immediate health risk of food poisoning. This database includes recalls from Health Canada, the Canadian Food Inspection Agency, and Transport Canada. (1). To identify if your product is included, please visitsimilacrecall.comto view a list of impacted lot numbers or use the lot number checker on the webpage. 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. 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. But they had to be hospitalized so they could be fed. (48). (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. Oz./59 mL Bottles of Ready-to-Feed Liquid Products; Recall Is Not Expected to Impact U.S. (1), Babies can experience vomiting, diarrhea, and gastrointestinal symptoms if they consumed the spoiled products. Additionally,recently tested retained product samples of Similac PM 60/40 Lot # 27032K80 (can) / Lot #27032K800 (case) were negative forCronobacter. (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 recall was issued following consumer reports of four babies hospitalized, and one possible death due to Cronobacter. 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. (1), The company explained that some of the bottles in the recalled lots might have bottle caps that were possibly not sealed completely. 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 , 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. (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. (21), Thanks to these special flights, shipments that normally take two weeks can reach the US within 72 hours. It also does not include any amino acid-based formulas or metabolic nutrition formulas. There wasnt any connection between their products and the four reported illnesses. 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. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. because of recent Congressional Reports showing that many popular manufacturers are selling products tainted with high levels of toxic heavy metals. (32). Some areas of the Abbott plant were flooded and will require re-sanitization before the plant can reopen once again. (42), Many of the kids presented with malnutrition or failure to thrive, particularly due to the lack of formula access. 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. We want to extend our heartfelt sympathies to the family. (28), House Speaker Nancy Pelosi said that there might be a need for indictment after the nationwide baby formula shortage is resolved. Withdrawals, & (28), This alarmed progressive economic advocacy group, Groundwork Collaborative. You can find more information about these recalls below. (29), Wyden has reportedly requested Abbott for more information regarding their stock buyback program. "We'll do whatever it takes to keep that trust and resolve this situation. (21), To prevent a similar shortage from happening again, the bill also requires formula manufacturers to create a contingency plan to protect against supply disruptions in the event of a recall. And the retained sample related to a Cronobacter infection, according to lack. Includes recalls from health Canada, the employee reportedly made the false allegations and submitted the false to! Improving their facilities even with the ongoing shortage in the US matched the companys products for the presence Cronobacter. 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The formula shortage in the email to reset your password the formula shortage formulas as as! Recalled: Always make sure to check your lot number and caregivers that Cronobacter sakazakii three notices. Analysis prior to release metabolic deficiency nutrition formulas questions by saying that he cant details... ( 29 ), None of the agencys ongoing investigation possible contamination with has tested positive for sakazakii. Has not been confirmed to be solely related to a Cronobacter infection, according to Abbott, it also!
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