In response, Abbott reportedly told the committee that the first report came in September from Minnesota health officials. FDA does not endorse either the product or the company. * Offers may vary. (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. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. A review of Abbott's records show that the company has destroyed products in the past due to the presence of Cronobacter. 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). (29), This huge increase includes a $76 million increase in food safety funding to improve technology to quickly trace the source of foodborne illnesses and other efforts to reduce toxins in food. (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. (28). They havent confirmed how many formula units have been recalled. 360 Whole-Baby Support: Nutrition designed for immune support, brain development, and digestive health; Helps Strengthen the Immune System: Similac 360 Total Care is designed to help strengthen baby's immune system; Convenient & Ready to Use: Great for on-the-go and late-night feeding; no mixing required . This recall was done after the death of another infant who tested positive for Cronobacter sakazakii. Food safety advocates are furious over how the FDA and Abbott handled these safety issues, especially because their lapses may have caused the death of at least two babies. (48). This case is under investigation, and at this time the cause of the infantsCronobacter sakazakiiinfection has not been determined. Califf announced, instead, that Abbott could restart production in a week or two, pending safety upgrades and certifications. Around 50% of the market demand comes from the WIC program (Special Supplemental Nutrition Program for Women, Infants, and Children). It may cause a decrease in vitamin C levels over time. (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. (45), As the formula shortage drove desperate parents to find online options, there were reports of products being offered on eBay for as high as $800, despite normally costing $43 to $47. (45), Abbott Nutrition recently announced that theyre releasing some metabolic nutrition and specialty formulas amid the infant formula shortage. It may also cause bowel damage and can spread through the blood to other parts of the body. (3), Symptoms of sepsis and meningitis can include: (2). (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 does not include any amino acid-based formulas or metabolic nutrition formulas. Abbott assured the public that they are taking this very seriously and working closely with the FDA to implement corrective actions. (51)(52). Now you can switch to digital savings by phone on your favorite formulasheres how: Thanks, but I'll stick with paper for now. (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). Similac and other formulas will be next in line once production starts. If you still wish to opt-out, please click the button below to confirm. The recalled products have been sold across the country. (28), However, Abbott denies that the buyback program hurt their products safety. (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. 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. At least two kids have been hospitalized in direct connection with the formula shortage. Contact the store or manufacturer for the refund or replacement process. (45), For faster production, the Biden administration asked manufacturers to simplify product offerings. Similac 360 Total Care Infant Formula, with 5 HMO Prebiotics, Our Closest Formula to Breast Milk, Non-GMO, . 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. Call Similac for refund processing or product replacement. Cronobacter infections are rare but can be especially dangerous for newborn babies. If a product is included in the recall,do not use the product. If the product is part of the recall, immediately stop giving it to your child, especially recalled products with Salmonella and other pathogens. (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. (50), The company insists that despite their products being the center of the issue, their investigations showed these arent the source of the infections. 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. (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. Abbott said it would restart EleCare production, upon reopening, followed by specialty and metabolic formulas. We want to extend our heartfelt sympathies to the family. 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. 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. (42). (42). Enfamil NeuroPro Sensitive 19.5 oz . According to Abbott, it will also resume the production of Similac and other formulas as soon as possible. (12), Just days after finally reopening since shutting down in February, Abbott Nutritions Sturgis plant closes again due to floods affecting the area. 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. Instead, theyll be distributed to pharmacies, hospitals, and doctors offices first. Childrens Wisconsin warns that homemade formula can cause liver and/or kidney damage. 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. 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. 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. Similac Pro-Advance Non-GMO Infant Formula with Iron, Earths Best Non-GMO Soy-Based Infant Powder Formula, Else Plant-Based Complete Nutrition for Toddlers, Baby Wipes Recall 2022: Affected Brands & Toxic Products, Similac Pro-Sensitive Vs. Similac Sensitive, Similac Pro-Sensitive Vs. 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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. (37), Currently, 90% of the US formula market is dominated by just four players: (37), These four companies also dominate the federal contracts for the WIC program for low-income families, which accounts for 50% of US formula productions. The site is secure. 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. Inspect domestic and international suppliers. The FDA had actually conducted plant inspections in September. Additionally, retained samples related to the three complaints forCronobacter sakazakiitested negative forCronobacter. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. It was the facility shut down in February following the massive Similac recall. 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. The recall does not include any metabolic deficiency nutrition formulas. 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 . 02.17.2022 -Abbott initiated a proactive, voluntary recall of powder formulas, including Similac, Alimentumand EleCare,manufactured in Sturgis, Michigan, one of the companys manufacturing facilities. (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. (4), Thats why theres also a shortage in the store brands like. This investigation is ongoing. According to DeLauro, the whistleblower (name withheld for security reasons) wrote a 34-page report with a long list of allegations about security lapses and unsafe practices at the plant. 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. ", Dunkin' fans heated over rewards program change, Time running out to claim child tax credits, stimulus checks, Florida orange crop declines after Hurricane Ian damage, Burger King adds spicy Ghost Pepper Whopper for Halloween, "If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur.". (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. (28), This alarmed progressive economic advocacy group, Groundwork Collaborative. Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. (55), The formula is safe to consume, but incorrect preparation using the provided scoop might not provide enough nutrients for your babys normal growth. 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. (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. 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. Prevent fake or fraudulent products from reaching store shelves. 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