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. (19). And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella Newport. (1). Abbott said it would restart EleCare production, upon reopening, followed by specialty and metabolic formulas. 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. It also does not include any amino acid-based formulas or metabolic nutrition formulas. They believe that having a leader in this position can unify and improve the FDAs food program. How many infants were fed contaminated formula during this time? (44), According to Abbott Nutrition, theyll prioritize producing Alimentum, EleCare, and metabolic formulas. Similac recalls several powdered formulas for possible contamination that can cause Cronobacter sakazakii and Salmonella Newport infection. Similac and other formulas will be next in line once production starts. (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. But something must be done to correct this serious safety concern. After the recall, however, they had to try other formula options but were unable to tolerate them, leading to dehydration. 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., Findings released by federal safety inspectors on March 22, 2022, show that Abbotts Sturgis, Michigan manufacturing plant involved in the recent Similac recall had several safety issues. (1)(2), Parents are advised to check the packaging of their Similac powdered formulas. (53), Formulas that dont meet this requirement need a label indicating that additional iron might be necessary, but the company failed to comply. During testing in our Sturgis, Mich., facility, we found evidence of Cronobacter sakazakii in the plant in non-product contact areas. As of May 8, 2022, market research company Datasembly estimates that 43% of the top-selling formula brands are out of stock. This recall doesnt include any metabolic deficiency nutrition formulas, Abbott liquid formulas, or other nutrition products. Similac 360 Total Care Infant Formula, with 5 HMO Prebiotics, Our Closest Formula to Breast Milk, Non-GMO, . To identify if your product is included, please visit similacrecall.com to view a list of impacted lot numbers or use the lot number checker on the webpage. (43). (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. Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. Instead, theyll be distributed to pharmacies, hospitals, and doctors offices first. Rakeen Mabud, the groups chief economist, pointed out that instead of improving its plant and making productive investments, Abbott chose to prioritize its shareholders. (61). One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. (37). Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. Crouse said that the exact number of children hospitalized relating to the formula shortage isnt available, but its apparent that theyve had several of these admissions. We want to extend our heartfelt sympathies to the family. Additionally, as part of Abbotts quality processes, we conduct routine testing for Cronobacter sakazakii and other pathogensin our manufacturing facilities. (36). It is therefore important to verify the product lot number on the bottom or the side of the bottle. 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. 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. As of press time, Abbotts Sturgis plant remains closed. On February 18, the Canadian Food Inspection Agency (CFIA) issued a recall for certain Abbott brand Similac powdered . The case remains under investigation, with authorities still trying to determine the cause of the infants Cronobacter sakazakii infection. 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. (2), Cronobacter can cause severe, life-threatening infections such as sepsis or meningitis (inflammation of the membranes protecting the brain and spine), according to the CDC (Centers For Disease Control And Prevention). If you still wish to opt-out, please click the button below to confirm. FDA Commissioner Dr. Robert Califf is the first administration official to face Congress in an investigation of the baby formula shortage. Enfamil NeuroPro Sensitive 19.5 oz . (41), Jennifer Crouse, the Clinical Nutrition Manager of Childrens Wisconsin, disclosed that several children have also been admitted to their hospital or treated at the ER. 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. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. 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. Bing Guan/Reuters Moms may have different reasons for choosing a particular formula for their babies. The massive recalls worsened the formula shortage in the US that first started with supply chain issues. (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. powder . (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. 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. (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 products included in the recall were manufactured at our Columbus, Ohio, manufacturing facility. Scott Stoffel, Abbotts spokesperson, confirmed that theyve been informed about the Justice Departments investigation and are cooperating fully. (7), It has been almost a year since the formula shortage crisis began in the US, yet it still persists despite efforts from the government and formula makers. (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. (4), Thats why theres also a shortage in the store brands like. Call Similac for refund processing or product replacement. (56), The formula has a much lower iron content than the concentration indicated on the label. 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. (2)(3). 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. 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 U.S. Food and Drug Administration is advising consumers not to use some powdered baby formulas after identifying four bacterial infections linked to the products. We found no evidence ofSalmonellaNewport. Click on the "Learn More" button to see lot numbers included in the recall or scroll down to Check Lot Number. Groups are calling on FDA officials to make food safety a priority to avoid a repeat of the formula crisis. So, Abbott includes this specialty product in the items being released along with these metabolic products: (47), Abbott assures consumers that these products have been tested, werent included in the recall, and comply with all the product release requirements before distribution. Why did it take four months to pull this formula off store shelves? (28), However, Abbott denies that the buyback program hurt their products safety. It also called for the appointment of a strong leader and the reorganization of the FDAs food program. Abbott also reminds parents and caregivers that Cronobacter sakazakii can be commonly found in the environment and a variety of areas around the home. Many parents are closely monitoring infant formula and. When you buy through links on our site we may earn an affiliate commission. But there were no serious medical complaints reported concerning this Similac recall. According to Abbott, it will also resume the production of Similac and other formulas as soon as possible. A review of Abbott's records show that the company has destroyed products in the past due to the presence of Cronobacter. This investigation is ongoing. The shipment was taken to the Nestle distribution center about a mile away for standard quality control checks. (29). Still, parents are also having trouble finding these products for their babies. Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. (30), Although she called the shortage unconscionable and tragic, Pelosi didnt specify the details of the possible indictment. However, she clarified that her remarks about the need for criminal charges arent associated with any of her colleagues. because of recent Congressional Reports showing that many popular manufacturers are selling products tainted with high levels of toxic heavy metals. (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. We are voluntarily initiating this recall because a small percentage of bottles in the recalled lots have bottle caps that may not have sealed completely, which could result in product spoilage. If you have questions, please contact Abbott's Consumer Relations hotlines below in the country where you received product: Join Similac Rewards for up to $400*in benefits and support throughout your journey. Jaundice (yellow skin and whites of the eyes). 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. On February 18, Abbott brand powdered infant formula products sold across the country have been flagged and recalled by the CIFA as there is the possibility of Cronobacter sakazakii and . (31), This next shipment from Ramstein Air Base is expected to land in Pennsylvania for distribution by the Nestle facility in the area. (11), According to the FDA, the infant death reportedly happened in January. It was the facility shut down in February following the massive Similac 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. (7). CNN Abbott Labs said Friday that it is recalling certain lots of 2 fluid ounce/59 milliliter bottles of Ready-to-Feed liquid formula for infants and children due to a problem with the bottle caps. 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. 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. (48). (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. (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. (7), When Abbott shut down from February to June 2022, it worsened the already existing formula shortage. The FDA clarifies that the recall is still in effect even though the investigation is closed. It may cause a decrease in vitamin C levels over time. The FDA had actually conducted plant inspections in September. (28), This alarmed progressive economic advocacy group, Groundwork Collaborative. . 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. Abbott clarifies that no distributed product (Similac PM 60/40 or the previously recalled Similac, Alimentum, and EleCare powdered infant formulas) tested positive for the presence of Cronobacter sakazakii. But they had to be hospitalized so they could be fed. They havent confirmed how many formula units have been recalled. Still, parents are also having trouble finding these products for their babies. "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. Priority will be given to worst-hit regions, a Biden administration official said. 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. You can find more information about these recalls below. (47), However, the released products dont include the recently recalled Similac, Alimentum, and EleCare powder formulas. During testing in our Sturgis, Michigan, facility, we found evidence ofCronobacter sakazakiiin the plant in non-product contact areas. This can result in spoilage. Cronobacter infections are rare but can be especially dangerous for newborn babies. (42). (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 take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. (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. Before sharing sensitive information, make sure you're on a federal government site. However, although the second bill (emergency spending bill) was also passed, it was received with more resistance from Republican representatives. (30), To directly address the formula shortage, Biden invoked the Defense Production Act on May 18, 2022. Find the answers below. And the retained sample related to the complaint forSalmonellaNewport tested negative forSalmonella. 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. (60), According to the FDA, premature babies fed with this formula for over a month may have a higher risk of developing iron-deficiency anemia because of insufficient iron intake. Amid the formula shortage following the massive Similac recall earlier this year, many parents continue to face challenges in finding products for their children. For all feeding-related questions or questions about your childs health, contact a healthcare professional. Retail companies like Walmart have already put a cap on how many you can buy per transaction. 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 , (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. You can check if your powdered formula is affected by inspecting the code printed near the expiration date. Additionally, as part of Abbott's quality processes, we conduct routine testing forCronobacter sakazakiiand other pathogensin our manufacturing facilities. Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. Had to try other formula options but were unable to tolerate them, leading to.... Does not include any metabolic deficiency nutrition formulas, Abbott liquid formulas, or other nutrition products rare. 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