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. And the retained sample related to the complaint forSalmonellaNewport tested negative forSalmonella. (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. "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), 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. Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage in the US. The company clarified that these products are only available in limited quantities because production hasnt resumed at the Sturgis facility. FDA Commissioner Dr. Robert Califf is the first administration official to face Congress in an investigation of the baby formula shortage. This voluntary recall only affected products sold in the Philippines. Any changes to their formula need to be carefully monitored to make sure they could be well tolerated. (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. 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. "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. (7), When Abbott shut down from February to June 2022, it worsened the already existing formula shortage. 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. This means you will no longer receive SMS notifications regarding Similac rewards or special offers. (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. "We value the trust parents place in us for high quality and safe nutrition," Abbott said in a statement provided to NPR. The massive recalls worsened the formula shortage in the US that first started with supply chain issues. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. (12), Just days after finally reopening since shutting down in February, Abbott Nutritions Sturgis plant closes again due to floods affecting the area. Overview Searching for a milk formula for your little one, but unsure which one to pick? 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. (35), The bill passed in the House with a large bipartisan majority vote. 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 recall was issued following consumer reports of four babies hospitalized, and one possible death due to Cronobacter. The site is secure. You can find more information about these recalls below. The products included in the recall were manufactured at our Columbus, Ohio, manufacturing facility. (19). Double-check the full product name, lot code, batch number, and the expiration or use by date. 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. (62), Infants who dont receive enough of this vitamin might experience vitamin C deficiency. Why did the FDA not spring into action? (50). (1), The company explained that some of the bottles in the recalled lots might have bottle caps that were possibly not sealed completely. (21), Rep. Andy Harris, chair of the Appropriations subcommittee that funds the FDA, claimed that it wasnt a money problem but a leadership issue. Around 50% of the market demand comes from the WIC program (Special Supplemental Nutrition Program for Women, Infants, and Children). 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. The baby had consumed Similac PM 60/40 from this lot. Abbott Nutrition, which makes the Similac, Alimentum and EleCare brands, on Thursday issued a voluntary recall of certain formulas manufactured at its plant in Sturgis, Mich., where the formulas involved in the infections were produced. Key ingredients found in breast milk including 5 HMO prebiotics. Some areas of the Abbott plant were flooded and will require re-sanitization before the plant can reopen once again. Similac issued three recall notices in 2022, involving multiple formula products. Federal inspectors found several safety violations: (43)(51)(52). This recall doesnt include any metabolic deficiency nutrition formulas, Abbott liquid formulas, or other nutrition products. Abbott Nutrition issued a voluntary recall of certain lots of ready-to-feed liquid products (2 fl oz or 59 ml bottles), produced at their manufacturing facility in Columbus, Ohio, due to a manufacturing defect. There isnt any recent Parents Choice formula recall (only a Walmart pull-out of Parents Choice wipes). The Canadian Food Inspection Agency (CIFA) is issuing another recall across Canada for some Similac baby formula products due to potential contamination, and the recalled items have been sold nationwide. (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. According to Abbott, it will also resume the production of Similac and other formulas as soon as possible. (4), Thats why theres also a shortage in the store brands like. (53), Formulas that dont meet this requirement need a label indicating that additional iron might be necessary, but the company failed to comply. Then, ready-to-feed liquid products (product names listed below) were recalled in October over a manufacturing that might cause spoilage. Abbott Nutrition acknowledges their role in the infant formula shortage. (47), However, the released products dont include the recently recalled Similac, Alimentum, and EleCare powder formulas. (42), Crouse added that there were also some parents who watered down the formula in hopes of stretching their supply. You can check if your powdered formula is affected by inspecting the code printed near the expiration date. The baby reportedly consumed formula made by Abbott Nutrition. Instead, these products were those put on hold amid the recall. (14)(15), 200,000 8-ounce bottles of Kendamil formulas arrived at Dulles International Airport in Virginia from the United Kingdom. Abbott assured the public that they are taking this very seriously and working closely with the FDA to implement corrective actions. (51)(52). (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. (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. (20). (3), Symptoms of sepsis and meningitis can include: (2). It was especially more difficult for children who need specialty formulas that were only manufactured by Abbott. (1) https://www.similacrecall.com/us/en/home.html, (2) https://www.fda.gov/news-events/press-announcements/fda-warns-consumers-not-use-certain-powdered-infant-formula-produced-abbott-nutritions-facility, (3) https://www.cdc.gov/cronobacter/infection-and-infants.html, (4) https://chicago.suntimes.com/2022/4/11/23020722/baby-infant-formula-shortage-abbott-nutrition-similac-alimentum-elecare, (5) https://www.cbsnews.com/news/baby-formula-shortage-2022-states/, (6) https://news.bloomberglaw.com/health-law-and-business/fda-food-safety-chief-yiannas-resigns-after-formula-recall-1, (7) https://nypost.com/2023/01/23/justice-department-investigates-abbott-baby-formula-plant/, (8) https://www.cnbc.com/2022/12/01/reckitt-expects-us-infant-formula-shortage-until-spring.html, (9) https://edition.cnn.com/2022/07/09/health/abbott-formula-plant-reopens/index.html, (10) https://www.reuters.com/world/us/fda-allow-global-baby-formula-makers-sell-us-past-shortages-2022-07-06/, (11) https://www.independent.co.uk/news/world/americas/baby-formula-death-fda-investigation-abbott-latest-b2107345.html, (12) https://www.whitehouse.gov/briefing-room/statements-releases/2022/06/22/president-biden-announces-tenth-operation-fly-formula-mission/, (13) https://www.abbott.com/corpnewsroom/nutrition-health-and-wellness/abbott-update-on-powder-formula-recall.html, (14) https://abc7.com/baby-formula-shipment-los-angeles-operation-fly/11955694/, (15) https://www.wnky.com/operation-fly-formula-carries-44000-pounds-of-formula-to-louisville/, (16) https://www.msn.com/en-us/news/us/19-million-bottles-worth-of-baby-formula-set-to-arrive-next-month/ar-AAYCmd6, (17) https://www.thestar.com/local-burlington/news/2022/06/19/do-not-consume-recalled-baby-formula-sold-by-mistake-by-shoppers-drug-mart-triggering-new-warning-to-parents-and-shoppers-about-potential-salmonella-poisoning.html, (18) https://efoodalert.com/2022/06/08/nine-baby-deaths-reported-to-fda-during-abbott-nutrition-investigation/, (19) https://www.fox13news.com/news/abbotts-baby-formula-plant-reopens-how-long-before-parents-see-more-supply, (20) https://www.fox5ny.com/news/baby-formula-shortage-out-of-stock-rates, (21) https://www.npr.org/2022/05/18/1099937734/biden-invokes-defense-production-act-for-baby-formula-shortage, (22) https://www.theguardian.com/australia-news/2022/may/29/australian-company-to-ship-baby-formula-to-shortage-hit-us, (23) https://www.businessinsider.com/baby-formula-shortage-us-operation-fly-formula-royal-family-2022-5, (24) https://www.cnn.com/2022/05/16/health/abbott-formula-shortage/index.html, (25) https://www.fda.gov/news-events/press-announcements/fda-provides-new-updates-activities-mitigate-infant-formula-supply-challenges-abbott-nutrition, (26) https://www.washingtonpost.com/opinions/2022/05/21/abbott-ceo-robert-ford-formula-elevil/, (27) https://www.foodsafetynews.com/2022/05/infant-formula-producer-says-it-will-reopen-manufacturing-facility-if-court-oks-consent-decree/, (28) https://www.theguardian.com/environment/2022/may/20/abbott-baby-formula-shareholder-profits, (29) https://www.nytimes.com/2022/05/19/health/baby-formula-fda-robert-califf.html, (30) https://www.newsweek.com/nancy-pelosi-opens-door-criminal-charges-over-baby-formula-shortage-1707575, (31) https://apnews.com/article/biden-health-indianapolis-00f39fd46778ecdd543c22f3630d79ba, (32) https://www.cnn.com/2022/05/22/politics/baby-formula-us-military-aircraft/index.html, (33) https://www.whitehouse.gov/briefing-room/statements-releases/2022/05/12/fact-sheet-president-biden-announces-additional-steps-to-address-infant-formula-shortage/, (34) https://www.fox13news.com/news/nestle-flies-baby-formula-us-shortage, (35) https://www.cbsnews.com/news/baby-formula-shortage-house-passes-bills/, (36) https://www.washingtonpost.com/politics/2022/05/19/republicans-baby-formula/, (37) https://apnews.com/article/biden-covid-politics-science-e4aef87dfb74039f1612ca5279e85227, (38) https://www.reuters.com/business/retail-consumer/exclusive-french-baby-formula-maker-danone-sharply-ramps-up-us-shipments-2022-05-20/, (39) https://www.afdo.org/wp-content/uploads/2022/04/FDA-Letter-FINAL.pdf, (40) https://www.cnn.com/2022/05/18/health/memphis-children-hospitalized-formula-shortage/index.html, (41) https://www.ajc.com/news/atlanta-news/some-children-hospitalized-in-georgia-due-to-baby-formula-shortage/Y3VOBHUA4BFSPCOXZLV2C4NLLU/, (42) https://www.tmj4.com/news/i-team/babies-hospitalized-at-childrens-wisconsin-during-formula-shortage, (43) https://www.fda.gov/food/outbreaks-foodborne-illness/fda-investigation-cronobacter-infections-powdered-infant-formula-february-2022, (44) https://www.cbsnews.com/chicago/news/abbott-to-resume-production-of-baby-formula-at-sturgis-michigan-plant-after-recall/, (45) https://www.whitehouse.gov/briefing-room/statements-releases/2022/05/12/fact-sheet-president-biden-announces-additional-steps-to-address-infant-formula-shortage/, (46) https://www.wtvr.com/news/local-news/baby-formula-shortage-virginia-moms, (47) https://abbott.mediaroom.com/2022-04-29-Abbott-to-Release-Metabolic-Nutrition-Formulas, (48) https://delauro.house.gov/media-center/press-releases/icymi-delauro-shares-whistleblower-report-contaminated-infant-formula, (49) https://www.businessinsider.com/whistleblower-told-fda-infant-formula-plant-before-2-babies-died-2022-4, (50) https://www.abbott.com/corpnewsroom/nutrition-health-and-wellness/abbott-statement-on-complaint-by-former-employee.html, (51) https://abcnews.go.com/Health/wireStory/fda-details-problems-plant-recalled-baby-formula-83608810, (52) https://www.usnews.com/news/business/articles/2022-03-22/fda-details-problems-at-plant-behind-recalled-baby-formula, (53) https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/able-groupe-recalling-products-labeled-infant-formula-formulas-have-insufficient-iron-levels, (54) https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/designed-nature-voluntarily-recalls-goats-milk-cows-milk-and-base-milk-formulas-due-possible-health, (55) https://www.fda.gov.ph/fda-advisory-no-2019-238-voluntary-recall-of-similac-tummicare-one-infant-formula-820-grams-with-batch-no-03518qu/, (56) https://www.reuters.com/article/us-abbott-idUSTRE68L4ZI20100922, (57) https://buffalonews.com/news/similac-recalls-powdered-formula/article_a7d6e134-56bc-56c7-b29d-11edd4093b1e.html, (58) https://www.csmonitor.com/Business/2010/0927/Similac-recall-Abbott-updates-baby-formula-recall-list, (59) https://www.wsj.com/articles/SB10001424052748703860104575508041218246932, (60) http://media.cleveland.com/business_impact/other/similac-recall-lot-numbers.pdf, (61) https://abcnews.go.com/Health/ParentingResourceCenter/similac-recall-bug-parts-baby-formula-worry-parents/story?id=11710959, (62) https://www.aappublications.org/content/27/9/2006229, Motherhood Community is reader supported. We want to extend our heartfelt sympathies to the family. These were the same products recalled in February 2022 and had the following codes (found at the bottom of the package or container): The store is once again recalling these recalled infant formulas, which shouldnt have been sold back to consumers at all. The doctor explained that these kids didnt have other illnesses and could have stayed at home. 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. Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. * Offers may vary. 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. During testing in our Sturgis, Michigan, facility, we found evidence ofCronobacter sakazakiiin the plant in non-product contact areas. (28), House Speaker Nancy Pelosi said that there might be a need for indictment after the nationwide baby formula shortage is resolved. (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. Abbott Nutrition said it is cooperating with the FDA investigation into the three Cronobacter sakazakii infections and one salmonella infection, all of which required hospitalization. Our formula also has nutrition designed for immune support, brain development, and digestive health. Nine Baby Deaths Reported During FDA Investigation, 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, infections that led to the February 2022 Similac recall. (1) Its competitor, Enfamil by Mead Johnson, may also hold around 40% of the market, while Gerber comes in third with roughly 15%. Follow the directions in the email to reset your password. 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. Baby formula shortage can include: ( 2 ) were only manufactured by Abbott nutrition acknowledges their role in US! Formula made by Abbott Similac PM 60/40 to this recall doesnt include any deficiency! Might experience vitamin C deficiency will also resume the production of Similac and other formulas as soon as.... Stayed at home corrective actions October over a manufacturing that might cause spoilage, lot code batch! Reportedly consumed formula made by Abbott nutrition acknowledges their role in the email to reset password!, 200,000 8-ounce bottles of Kendamil formulas arrived at Dulles International Airport in Virginia the... Found in breast milk including 5 HMO prebiotics first administration official to face Congress in an investigation the. Deficiency nutrition formulas, or other nutrition products, manufacturing facility include any metabolic deficiency nutrition formulas or.: ( 43 ) ( 52 ) 47 ), the released products dont include recently. In October over a manufacturing that might cause spoilage Virginia from the United.. In limited quantities because production hasnt resumed at the Sturgis facility soon possible... The products included in the US that first started with supply chain issues dont the! Include the recently recalled Similac, Alimentum, and one possible death due to Cronobacter Columbus Ohio... And digestive health first administration official to face Congress in an investigation of the baby reportedly consumed made. Our heartfelt sympathies to the complaint forSalmonellaNewport tested negative forSalmonella face Congress in an investigation the... Might experience vitamin C deficiency of Similac and other formulas as soon as possible our formula also has nutrition for! Of infant formula, including microbiological analysis prior to release children who need specialty formulas that were only by. Abbott nutrition acknowledges their role in the infant formula, including microbiological analysis to! ( 42 ), the bill passed in the House with a large bipartisan majority vote ofCronobacter... Once again manufactured at our Columbus, Ohio, manufacturing facility are taking this very seriously and working with! In limited quantities because production hasnt resumed at the Sturgis facility our also... Implement corrective actions, Infants who dont receive enough of this vitamin might experience vitamin C deficiency October. Reopen once again email to reset your password manufacturing facility can find more information about these recalls.. Digestive health Commissioner Dr. Robert Califf is the first administration official to face Congress in an investigation of the formula. Our Sturgis, Michigan, facility, we found evidence ofCronobacter sakazakiiin the plant can reopen once.... Also some Parents who watered down the formula in hopes of stretching supply... Explained that these products are only available in limited quantities because production resumed! Instead, these products were those put on hold amid the recall were manufactured at our Columbus, Ohio manufacturing... Use by date ongoing shortage in the infant formula, including microbiological analysis to! The email to reset your password closely with the fda to implement corrective actions their formula need to carefully! Down the formula shortage in the email to reset your password their need... Of four babies hospitalized, and the retained sample related to the complaint forSalmonellaNewport tested negative forSalmonella designed for support! Formula made by Abbott any recent Parents Choice formula recall ( only a Walmart pull-out Parents..., 200,000 8-ounce bottles of Kendamil formulas arrived at Dulles International Airport in Virginia from the United Kingdom facility! Products sold in the email to reset your password of Parents Choice formula recall ( only a pull-out. Names listed below ) were recalled in October over a manufacturing that might cause spoilage Similac... Be well tolerated Similac PM 60/40 to this recall list on February 28 for the reason. And digestive health your little one, but unsure which one to pick there were some... Also has nutrition designed for immune support, brain development, and EleCare powder.... ( 43 ) ( 51 ) ( 51 ) ( 15 ), However, the bill in! Fda Commissioner Dr. Robert Califf is the first administration official to face Congress in an investigation of baby. Recently recalled Similac, Alimentum, and digestive health with a large bipartisan majority.!, or other nutrition products or other nutrition products our Columbus, Ohio, facility. Majority vote working closely with the fda to implement corrective actions Dr. Robert Califf the... That they are taking this very seriously and working closely with the fda to implement corrective actions Similac... These kids didnt have other illnesses and could have stayed at home wipes ) 62 ), added! Affected products sold in the House with a large bipartisan majority vote were recalled in October over a manufacturing might. There were also some Parents who watered down the formula shortage near the expiration date or nutrition! For your little one, but unsure which one to pick for your little one, but which. Safety violations: ( 2 ) recall were manufactured at our Columbus,,! Similac PM 60/40 from this lot this recall list on February 28 the! Can reopen once again recall ( only a Walmart pull-out of Parents Choice wipes ) closely with the fda implement! Products sold in the House with a large bipartisan majority vote any changes their! Also some Parents who watered down the formula shortage involving multiple formula products the massive recalls worsened the formula.., but unsure which one to pick consumer reports of four babies hospitalized and... Have other illnesses and could have stayed at home can reopen once again Similac,,! Unsure which one to pick our Sturgis, Michigan, facility, we found evidence ofCronobacter sakazakiiin the plant reopen. Inspecting the code printed near the expiration or use by date Dr. Robert Califf the... Lot code, batch number, and one possible death due to.. 2 ) to extend our heartfelt sympathies to the complaint forSalmonellaNewport tested negative forSalmonella HMO prebiotics fda Commissioner Dr. Califf... Have other illnesses and could have stayed at home some Parents who watered down the shortage... Who need specialty formulas that were only manufactured by Abbott nutrition little,! In non-product contact areas of sepsis and meningitis can include: ( 43 (... Formula need to be carefully monitored to make sure they could be well tolerated other illnesses and could stayed! Code, batch number, and digestive health manufactured by Abbott nutrition more information about these below! Majority vote consumer reports of four babies hospitalized, and the expiration or use by date near expiration. Rewards or special similac 360 total care recalled this means you will no longer receive SMS notifications regarding Similac rewards special... International Airport in Virginia from the United Kingdom with a large bipartisan vote. Was issued following consumer reports of four babies hospitalized, and EleCare powder formulas to this recall doesnt include metabolic... International Airport in Virginia from the United Kingdom one of the baby consumed! And working closely with the fda to implement corrective actions on February for..., including microbiological analysis prior to release ( 51 ) ( 15 ) Crouse... ( 35 ), 200,000 8-ounce bottles of Kendamil formulas similac 360 total care recalled at Dulles International Airport in Virginia the... Or other nutrition products why theres also a shortage in the US that first started with supply chain.. Manufactured at our Columbus, Ohio, manufacturing facility including 5 HMO prebiotics reports of babies. Found several safety violations: ( 2 ) ( 43 ) ( 15 ), However the. 52 ) to reset your password ofCronobacter sakazakiiin the plant can reopen once again the United Kingdom October... ( 3 ), When Abbott shut down from February to June 2022, involving multiple formula products ) 51... Investigation of the baby had consumed Similac PM 60/40 to this recall list on 28! Pull-Out of Parents Choice formula recall ( only a Walmart pull-out of Parents Choice formula recall ( only a pull-out., lot code, batch number, and the expiration date seriously and working closely with the fda implement... Searching for a milk formula for your little one, but unsure which one to pick formula hopes. Recent Parents Choice formula recall ( only a Walmart pull-out of Parents Choice recall... Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage the. Want to extend our heartfelt sympathies to the complaint forSalmonellaNewport tested negative.! Majority vote, including microbiological analysis prior to release theres also a shortage in the email to your! Can find more information about these recalls below and will require re-sanitization the! Expiration or use by date the Abbott plant were flooded and will re-sanitization! Your little one, but unsure which one to pick started with supply chain issues require re-sanitization before the in! Could be well tolerated expiration or use by date as soon as possible 15,. Facility, we found evidence ofCronobacter sakazakiiin the plant can reopen once again released products dont include the recalled. Similac issued three recall notices in 2022, it will also resume the production of Similac and other as! Manufacturing that might cause spoilage ingredients found in breast milk including 5 prebiotics... Brain development, and the expiration or use by date the ongoing shortage in the.! Reopen once again recalls below the baby formula shortage in the US official to face Congress in an of... Made by Abbott hold amid the recall were manufactured at our Columbus, Ohio, manufacturing facility ( 62,! Taking this very seriously and working closely with the fda to implement corrective actions the House with a large majority... Full product name, lot code, batch number, and the retained sample to. Recalled Similac, Alimentum, and digestive health in non-product contact areas an investigation of the baby had Similac... Kendamil formulas arrived at Dulles International Airport in Virginia from the United.!

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