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. I am equally concerned that the FDA reacted far too slowly to this report. The recalled products didnt meet FDA requirements because the company didnt submit pre-market notifications. But these include Similac, Alimentum, and EleCare during the first recall, then Similac PM 60/40 in the second recall. (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. It also called for the appointment of a strong leader and the reorganization of the FDAs food program. (1), These products were distributed to some doctors offices, hospitals, distributors, and retailers in the US, Canada, Puerto Rico, Trinidad & Tobago, Curacao, Barbados, St Thomas, Jamaica, St Croix, Dominican Republic, Panama, Colombia, and Haiti. Still, parents are also having trouble finding these products for their babies. It was easier to increase the shipments because both were already being imported even before the shortage. 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. (37). (38), To meet the demands, Enfamil production has been increased to 30%, the company added. Contact 1800-10-995-1555 (Province), (02) 995-1555 (Manila), or, Several powdered baby formula products were recalled due to the remote possibility of contamination with larvae, full-grown adults, or insect parts of the small common beetle. Our formula also has nutrition designed for immune support, brain development, and digestive health. When you buy through links on our site we may earn an affiliate commission. This can result in spoilage. It also does not include any amino acid-based formulas or metabolic nutrition formulas. Contact the store or manufacturer for the refund or replacement process. 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. Select Similac baby products are part of a new recall. Importantly, no distributed product has tested positive for the presence ofCronobacter sakazakii. The company clarified that these products are only available in limited quantities because production hasnt resumed at the Sturgis facility. (21), Rep. Andy Harris, chair of the Appropriations subcommittee that funds the FDA, claimed that it wasnt a money problem but a leadership issue. (1)(2), Parents are advised to check the packaging of their Similac powdered formulas. 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. 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. (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. Directions apply to Chrome onAndroid devices. (37). The products included in the recall were manufactured at our Columbus, Ohio, manufacturing facility. Update password per the new system standards (8 Characters). Abbott also reminds parents and caregivers that Cronobacter sakazakii can be commonly found in the environment and a variety of areas around the home. Before the massive Similac recall, Abbott Nutrition topped the market spot with 40% of the market share, closely followed by the long-time number 2 player in the US, Enfamil. (8), Reckitt Benckiser, the maker of Enfamil and now the US largest formula supplier, operates its formula factories 24/7 but believes that the crisis will persist until spring. Between the lines: Abbott said the 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. It was especially more difficult for children who need specialty formulas that were only manufactured by Abbott. 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. (45), The White House released the additional measures they will follow to increase the formula products available without compromising babies safety: (45), The US typically produces nearly all (around 98%) of the infant formulas it needs. Similac and other formulas will be next in line once production starts. 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. (29). ", What's next: The company said it 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. (32), Another shipment with 114 pallets of Gerber Good Start Extensive HA formula from the Netherlands is expected to arrive via the second flight of Operation Fly Formula. (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. Similac 360 Total Care * Infant Formula is made with an exclusive blend of 5 HMO prebiotics structurally identical to those in breast milk. Additionally,recently tested retained product samples of Similac PM 60/40 Lot # 27032K80 (can) / Lot #27032K800 (case) were negative forCronobacter. However, issuing the voluntary recall was the right thing to do because they didnt want to risk the childrens lives and health. (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. 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. 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. How many infants were fed contaminated formula during this time? (13). The recall does not include any metabolic deficiency nutrition formulas. Similac 360 Total Care Sensitive 30.2 oz. This manufacturing defect may cause a decrease in the formulas vitamin C content over time. (21), Thanks to these special flights, shipments that normally take two weeks can reach the US within 72 hours. (26), He explained that none of the data matched between the specimen from the four complaints and of the retained product samples. To find out if the product you have is included in this recall, click on the button below to check your lot number. 8 oz (6 p ack) ready to feed . (32), The products originated from Zurich, Switzerland, and were trucked to Germany. Similac 360 Total Care Sensitive . Retail companies like Walmart have already put a cap on how many you can buy per transaction. Symptoms of a Cronobacter infection include poor feeding, jaundice and grunting breaths, according to the FDA. Two House bills were passed to address the shortage. (45), As the out-of-stock rates soared to 43%, the White House plans to increase formula importation from key sources, including Chile, Ireland, Mexico, and the Netherlands, to help meet the higher demands and lower supplies. Priority will be given to worst-hit regions, a Biden administration official said. There wasnt any connection between their products and the four reported illnesses. 83/ounce) Enfagrow Premium Powder Toddler Formula - 32oz . Additionally, as part of Abbott's quality processes, we conduct routine testing forCronobacter sakazakiiand other pathogensin our manufacturing facilities. 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. (42), Many of the kids presented with malnutrition or failure to thrive, particularly due to the lack of formula access. This recall was done after the death of another infant who tested positive for Cronobacter sakazakii. If your product is affected by this recall, dont use it even if it looks alright. Contains no artificial growth hormones and is non-GMO. Two recalled Similac products were sold between November 1, 2020, and February 17, 2022:. 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. Groups are calling on FDA officials to make food safety a priority to avoid a repeat of the formula crisis. You can check if your powdered formula is affected by inspecting the code printed near the expiration date. (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. How many infants were fed contaminated formula during this time?, In a statement, Abbott Nutrition wrote that they: (50), Abbott claimed that they dismissed this former employee (the whistleblower) due to serious violations of the companys food safety policies. Similac infant formula will be produced in "alternative product sizes and formats for delivery to retail locations, in addition to increased production throughout our global manufacturing network," Abbott said. 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). This case is under investigation, and at this time the cause of the infantsCronobacter sakazakiiinfection has not been determined. (11), According to the FDA, the infant death reportedly happened in January. Some brands have very similar packaging for different types of formula. We want to extend our heartfelt sympathies to the family. (36), Republican Conference Chair Elise Stefanik accused Bidens failed leadership, saying that its responsible for Americas baby formula crisis. This is subject to the FDAs approval. (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. Affected products have a code beginning with first two digits of 22 through 37 and containing K8, SH or Z2 and have an expiration date of April 1, 2022, or later. (40), They relied on the amino acids (building blocks of proteins) from EleCare for nourishment because these dont have to be digested. (53), Formulas that dont meet this requirement need a label indicating that additional iron might be necessary, but the company failed to comply. Alternatives To Similac & Other Recalled Baby Formulas, *Check out our interviews with Serenity Kids founders on their. If a product is included in the recall,do not use the product. 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 , (7). (41), A spokesperson for the hospital refused to disclose the exact number of hospitalized kids but said that all had specific dietary needs. However, Califf reportedly sidestepped these questions by saying that he cant share details of the agencys ongoing investigation. (30), To directly address the formula shortage, Biden invoked the Defense Production Act on May 18, 2022. Their first shipment will be Aptamil First Infant Milk Stage 1 (formula for healthy babies). 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. (31), The company representative added that theyre checking if they could tap into the Nestle global nutrition network for other formulas they could import after the FDA announced that companies are given temporary flexibility for importing baby formulas to address the shortage. In several parts of the US, several babies and even older children have been hospitalized amid the formula shortage. (47), However, the released products dont include the recently recalled Similac, Alimentum, and EleCare powder formulas. 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. (18), None of the DNA sequences in the FDA investigation matched the companys products. She added that buybacks were considered a form of manipulation and were illegal until 1982. (13). (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. (41)(42). 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. (20). Many European formulas arent approved by the FDA, although many parents still prefer them over US brands. 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. Abbott said it would restart EleCare production, upon reopening, followed by specialty and metabolic formulas. 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. ". The FDA had actually conducted plant inspections in September. (40), The two children (a toddler and a preschooler) were using EleCare, a specialty formula they needed because they both have short bowel syndrome and couldnt absorb full-size proteins. If the product is part of the recall, immediately stop giving it to your child, especially recalled products with Salmonella and other pathogens. There is a new recall in Canada for some Similac baby formula products due to potential microbial contamination and the affected products have been sold across the country. For all feeding-related questions or questions about your childs health, contact a healthcare professional. Why did the FDA not spring into action? Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. (42), Crouse added that there were also some parents who watered down the formula in hopes of stretching their supply. But there were no serious medical complaints reported concerning this Similac recall. (6), The US Justice Department, through its consumer protection branch, is reportedly conducting a criminal investigation over Abbotts possible role in the formula shortage. However, all these infants were fed Abbott powdered formulas: (18), Abbott Nutrition finally restarted its facility in Sturgis, Michigan, on June 4, 2022. The recall does not include any metabolic deficiency nutrition formulas. Only the specific brands, types, and sizes listed above are WIC approved. Bing Guan/Reuters The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. Moms may have different reasons for choosing a particular formula for their babies. (28), Also, she believes that restrictions should be imposed on companies that receive federal funding or in Abbotts case, companies whose largest customers are federal programs such as the WIC. (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). 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