(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. However, although the second bill (emergency spending bill) was also passed, it was received with more resistance from Republican representatives. (26), However, he clarified that they wouldnt tolerate having bacteria in their plant, something that the FDA found during their investigation. Moms may have different reasons for choosing a particular formula for their babies. On February 18, the Canadian Food Inspection Agency (CFIA) issued a recall for certain Abbott brand Similac powdered . In particular, this measure will let WIC participants buy any formula from any available supplier rather than be limited by the unavailable WIC-approved brand. These were loaded on one C-17 cargo plane at Ramstein Air Base in Germany and flown to Indianapolis. How many infants were fed contaminated formula during this time? 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. Failure to establish a system of process controls that covers all stages of processing to ensure that baby formula doesnt become contaminated due to the presence of microorganisms (e.g., bacteria) in the formula or in its processing environment. 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. Alternatives To Similac & Other Recalled Baby Formulas, *Check out our interviews with Serenity Kids founders on their. (47), Whistleblower Reportedly Notified The FDA About Security Lapses Months Before Recall, Hid information during a 2019 audit by the FDA (Food and Drug Administration). But there were no serious medical complaints reported concerning this Similac recall. 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. 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. (1)(2), Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. 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. FDA Commissioner Dr. Robert Califf is the first administration official to face Congress in an investigation of the baby formula shortage. (51)(52), The FDAs preliminary findings show the following: (51)(52), The Senate health committee asked Abbott to detail the amount of time it took them to start the recall from the first reported case. (31), Through the Operation Fly Formula, the first batch of formulas (78,000 lbs) arrived in the US to supply specialty infant formula. (11), According to the FDA, the infant death reportedly happened in January. We found no evidence ofSalmonellaNewport. And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella Newport. (1). (18), None of the DNA sequences in the FDA investigation matched the companys products. (28), American Economic Liberties Project senior fellow Moe Tkacik accused companies like Abbott of using their products as a personal ATM. The whistleblower alleged that Abbott Nutrition: (48), The whistleblower claims that this report was submitted to the FDA in October 2021, several months before the deaths of the babies and the February 2022 recall. hide caption. Symptoms may include irritability with generalized tenderness. It can even lead to an imbalance in your babys body that might cause their heart to stop. powdered infant formulas) was issued on February 17 due to possible contamination with. "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. It was also quickly approved by the Senate and is now up to Biden to sign into law. There isnt any recent Parents Choice formula recall (only a Walmart pull-out of Parents Choice wipes). (9), The FDA plans on allowing the import of overseas formulas from temporary importers to go beyond the shortage in a bid to prevent it from happening again. Still, parents are also having trouble finding these products for their babies. Recalls, Market Withdrawals, & Safety Alerts, Recalls, Market Withdrawals and Safety Alerts, Recalls, Market Withdrawals, & Safety Alerts, Archive for Recalls, Market Withdrawals & Safety Alerts, Abbott Voluntarily Recalls Certain Lots of 2 Fl. (1) Is Similac formula good for babies? They havent confirmed how many formula units have been recalled. This is subject to the FDAs approval. The .gov means its official.Federal government websites often end in .gov or .mil. I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. (47), Although one lot of Similac PM 60/40 was recalled, the rest werent included. The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of our Sturgis facility and has not been linked to the two available patient samples or any other known infant illness. Groups are calling on FDA officials to make food safety a priority to avoid a repeat of the formula crisis. 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. (1), Babies can experience vomiting, diarrhea, and gastrointestinal symptoms if they consumed the spoiled products. . 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 , At least two kids have been hospitalized in direct connection with the formula shortage. Directions apply to Chrome onAndroid devices. Only the specific brands, types, and sizes listed above are WIC approved. (29). powder . They can also find it from the list that the company later released. Otherwise, click Cancel to return to your profile. 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. Safety Alerts, Ready-to-feed liquid products for infants and children, An official website of the United States government, : There wasnt any connection between their products and the four reported illnesses. 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. (56), Call 800-986-8850 or visit similac.com/recall (the companys website for recalls), Similac Go & Grow Milk Early Shield Powder, When we identified this, we did extensive testing of every product on the (factory) line, and more than 99.8 percent of the product was negative for beetle contamination, , said Abbott spokeswoman Melissa Brotz. Recalls. Several groups are also calling on the FDA to restore the deputy food commissioner position removed during the Trump administration. This manufacturing defect may cause a decrease in the formulas vitamin C content over time. But even if production starts again, Abbott explained that it could take at least 6-8 weeks before the products will be available for distribution. . The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of our Sturgis facility and has not been linked to the two available patient samples or any other known infant illness. The company announced that it will prioritize EleCare production as well as other specialty and metabolic formulas for babies with severe food allergies and digestive problems. (49). However, even with the plants reopening, Abbott Nutrition estimates that the new products will only reach the store shelves in around six to eight weeks. (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. Theyre doing it to fulfill the FDAs request. It may cause a decrease in vitamin C levels over time. (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. 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. (27), According to Ford, none of the bacterial strains that caused the infection of four infants, killing two babies, were found in Abbotts products. Authorities are now investigating after Cronobacter was found to have possibly contributed to the death of one of the babies. They established an IMG (Incident Management Group) to continue working on these supply chain and food safety issues as the out-of-stock rates soared to 43%. (28), House Speaker Nancy Pelosi said that there might be a need for indictment after the nationwide baby formula shortage is resolved. Now you can switch to digital savings by phone on your favorite formulasheres how: Thanks, but I'll stick with paper for now. Their first shipment will be Aptamil First Infant Milk Stage 1 (formula for healthy babies). One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. Abbott also reminds parents and caregivers that Cronobacter sakazakii can be commonly found in the environment and a variety of areas around the home. Amid the formula shortage following the massive Similac recall earlier this year, many parents continue to face challenges in finding products for their children. . 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. 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. (1). (51)(52). This investigation is ongoing. So, its important to follow the instructions found on the packaging for proper preparation, handling, and storage of all powder formulas to avoid contamination. 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. (1), The company explained that some of the bottles in the recalled lots might have bottle caps that were possibly not sealed completely. These products were manufactured at the companys Columbus, Ohio, manufacturing facility and distributed primarily to hospitals, doctors offices, distributors, and some retailers in the US, including Puerto Rico; a limited number of products were sent to Canada, Colombia, the Dominican Republic, Panama, and certain countries in the Caribbean. Although its still unclear what impact this reopening might have on the baby formula shortage, Abbott Nutrition hopes that it can help improve the market supply. (56), The recall was based on an internal quality review. (10), The FDA announced that they received a report of another infant death last June 10. Additionally, as part of Abbotts quality processes, we conduct routine testing for Cronobacter sakazakii and other pathogensin our manufacturing facilities. 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. It isnt ideal for premature infants or those with digestive and metabolic issues. Why did the FDA not spring into action? So, major disruptions of these companies supplies, such as a massive recall like the February 2022 Similac recall, can greatly affect the formula supply in the market. 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. (19). (32), Another one was hospitalized due to mineral imbalances after their caregiver mixed their own formula. Although the formula shortage began in 2021, Abbotts massive recall worsened the problem. Around 50% of the market demand comes from the WIC program (Special Supplemental Nutrition Program for Women, Infants, and Children). First European Shipment Arrives In The US, House Passes $28 Million Emergency Spending & WIC Flexibility Bills. 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. 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. It was easier to increase the shipments because both were already being imported even before the shortage. 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. Contains no artificial growth hormones and is non-GMO. (28). (48). (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. (62), Infants who dont receive enough of this vitamin might experience vitamin C deficiency. (2)(3). They also need to promptly notify the FDA about the situation. Rakeen Mabud, the groups chief economist, pointed out that instead of improving its plant and making productive investments, Abbott chose to prioritize its shareholders. He admitted to reading the complaint but didnt specify when or what steps he took to immediately address the issue. (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. (31), Aside from ramping up productions, Biden also launched Operation Fly Formula. He directed various government agencies to use the Department of Defense planes to pick up formulas that meet U.S. standards overseas and fly these to the U.S. to help restock shelves. But these include Similac. Some options for you to try (US brands), with your pediatricians approval: *Check out our interviews with Serenity Kids founders on their toddler formula, and their baby food pouches. (56), The formula has a much lower iron content than the concentration indicated on the label. "We'll do whatever it takes to keep that trust and resolve this situation. Then, theyre marking these up for online retail at exorbitant prices. Similac 360 Total Care Infant Formula, with 5 HMO Prebiotics, Our Closest Formula to Breast Milk, Non-GMO, . (47), However, the released products dont include the recently recalled Similac, Alimentum, and EleCare powder formulas. The Sturgis plants reopening is expected to improve formula supplies in the market and alleviate the formula shortage problem soon. Democrats also proposed a $28 million emergency spending bill to supposedly boost the FDAs resources, including adding more staff. 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). Some might feel more secure choosing a well-known brand name. (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. (33), Formula makers quickly responded, with Nestle importing Alfamino from Switzerland and also Gerber Good Start Extensive HA from the Netherlands. (1). "We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need.". (7). (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. Similac 360 Total Care Sensitive . Similac 360 Total Care Sensitive 30.2 oz. (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. Theyre currently working with the FDA to implement corrective actions at the plant before they can resume production. (21), Rep. Andy Harris, chair of the Appropriations subcommittee that funds the FDA, claimed that it wasnt a money problem but a leadership issue. The recall does not include any metabolic deficiency nutrition formulas. (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. The second bill ( emergency spending & WIC flexibility Bills and resolve this situation may have reasons. Consumed the spoiled products infants or those with digestive and metabolic issues Similac 360 Total infant... Ramstein Air Base in Germany and flown to Indianapolis recent Parents Choice wipes ) for Abbott. If they consumed the spoiled products often end in.gov or.mil pull-out of Parents Choice formula recall only! Economic Liberties Project senior fellow Moe Tkacik accused companies like Abbott of using their products as a personal.... ( 2 ), although one lot of Similac PM 60/40 was recalled, the Canadian food Inspection Agency CFIA. Priority to avoid a repeat of the Baby formula shortage Robert Califf is the first administration to. 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