(26), However, he clarified that they wouldnt tolerate having bacteria in their plant, something that the FDA found during their investigation. (3), Symptoms of sepsis and meningitis can include: (2). (1) Is Similac formula good for babies? At least two kids have been hospitalized in direct connection with the formula shortage. (55), Batch no. "We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need.". (1). "We'll do whatever it takes to keep that trust and resolve this situation. (41)(42). Similac recalls several powdered formulas for possible contamination that can cause Cronobacter sakazakii and Salmonella Newport infection. But there were no serious medical complaints reported concerning this Similac recall. Why did the FDA not spring into action? (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. 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. Bing Guan/Reuters "We value the trust parents place in us for high quality and safe nutrition," Abbott said in a statement provided to NPR. Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. 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. On February 18, the Canadian Food Inspection Agency (CFIA) issued a recall for certain Abbott brand Similac powdered . powdered infant formulas) was issued on February 17 due to possible contamination with. (12), These flights will arrive starting on June 24. This is in addition to lots of Similac, Alimentumand EleCarepowder formula that were voluntarily recalled on Feb. 17. It may control as much as 40% of the market. The FDA requires formula manufacturers to meet this requirement to help prevent iron deficiency anemia, a condition that can lead to irreversible functional development outcomes. (12), Just days after finally reopening since shutting down in February, Abbott Nutritions Sturgis plant closes again due to floods affecting the area. (1)(2), Then, ready-to-feed liquid products (product names listed below) were recalled in October over a manufacturing that might cause spoilage. Any changes to their formula need to be carefully monitored to make sure they could be well tolerated. 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. 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. (7), It might have played a big role in the shortage and can be held liable, depending on the outcome of the Justice Departments investigation. 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. Some of these facility improvements include the following: (44), US President Joe Biden met with infant formula manufacturers and retailers, including Reckitt, Gerber, Walmart, and Target, to discuss strategies to get more formula quickly yet safely onto store shelves to solve the ongoing shortage. They believe that having a leader in this position can unify and improve the FDAs food program. (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. Call Similac for refund processing or product replacement. (11), According to the FDA, the infant death reportedly happened in January. 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. 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. 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. (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 360 Total Care Infant Formula, with 5 HMO Prebiotics, Our Closest Formula to Breast Milk, Non-GMO, . Cronobacter infection can be deadly, especially to newborns. So, its important to follow the instructions found on the packaging for proper preparation, handling, and storage of all powder formulas to avoid contamination. Similac issued three recall notices in 2022, involving multiple formula products. (51)(52). (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. The massive recalls worsened the formula shortage in the US that first started with supply chain issues. 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. The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. Those infected with salmonella might experience fever, diarrhea and abdominal cramps. Why it matters: About 3 in 4 babies are fed formula by six months old as a complete or partial substitute for human milk, Axios' Nathan Bomey reports. (56), It affected products made at a plant in Sturgis, Michigan. 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. First European Shipment Arrives In The US, House Passes $28 Million Emergency Spending & WIC Flexibility Bills. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. They can also find it from the list that the company later released. Consolidation Makes Formula Market Vulnerable, Reckitt Benckiser (Mead-Johnsons Enfamil), Making Food Safety A Priority To Avoid Repeat Of Formula Crisis, Babies Hospitalized Due To Formula Shortage, Two Children Hospitalized Because Their Specialty Formula Is Out Of Stock, Babies Hospitalized For Intolerance To New Formula & Mineral Imbalances, Undisclosed Number Of Children Hospitalized in Georgia, Undisclosed Number Of Kids Hospitalized in Wisconsin, Abbott Nutrition To Reopen Sturgis Plant Involved In Recall, According to Abbott Nutrition, theyll prioritize producing, and other formulas will be next in line once production starts. Learn More. (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. 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. (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. Our formula also has nutrition designed for immune support, brain development, and digestive health. Abbott Nutrition acknowledges their role in the infant formula shortage. (56), The recall was based on an internal quality review. It was also quickly approved by the Senate and is now up to Biden to sign into law. Tests of retained product samples from the recalled Similac PM 60/40 lot were negative for Cronobacter. 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. However, although the second bill (emergency spending bill) was also passed, it was received with more resistance from Republican representatives. (32), Another one was hospitalized due to mineral imbalances after their caregiver mixed their own formula. (47). Infant Formula Supply, Recent Recalled Product Photos on FDA's Flickr Photostream. (28), House Speaker Nancy Pelosi said that there might be a need for indictment after the nationwide baby formula shortage is resolved. Abbott Nutrition is recalling certain lots of ready-to-feed liquid baby products, including several under its Similac brand, for potential spoilage, the company said Friday. (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. Still, the experience pushed economists to call for bans on buybacks, stricter antitrust enforcement, and limits on shareholder dividends. 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. (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. One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. These specialty formulas were prioritized because theyre in short supply in the US and serve a critical medical purpose for children with cows milk protein allergies. 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. It may also cause bowel damage and can spread through the blood to other parts of the body. 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. 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. Similac 360 Total Care * Infant Formula is made with an exclusive blend of 5 HMO prebiotics structurally identical to those in breast milk. 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. The site is secure. It is therefore important to verify the product lot number on the bottom or the side of the bottle. (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. Some brands have very similar packaging for different types of formula. (20). (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. However, the baby formula shortage from supply chain issues and the Similac recalls reduced the available products. (31), However, these specialty formulas arent expected to hit retail store shelves. Instead, these products were those put on hold amid the recall. The Sturgis plants reopening is expected to improve formula supplies in the market and alleviate the formula shortage problem soon. 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. (41), A spokesperson for the hospital refused to disclose the exact number of hospitalized kids but said that all had specific dietary needs. (62), Lot codes 40177RH and 40172RH, with a use by date of Nov. 1, 2007, The bottles lack a special layer that keeps air out. 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. 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. 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