October 6, 2022

Similac Alimentum Infant Formula Recalled For Packaging Defect

Similac Alimentum Infant Formula is being recalled for a possible packaging defect. This recall notice was posted on the FDA's Enforcement Report web page on September 7, 2022, and is not on the usual FDA recall page, so we do not know if any adverse events have been reported to the company to date. The recalling firm is Abbott Nutrition of Columbus, Ohio. The recalled product is Similac Alimentum Infant Formula that is packaged in 32 ounce re-closable plastic bottles. There are eight bottles in each case, and about 720 bottles are included in this recall. The Batch/Lot Number that is stamped on each bottle is  41740RH00. The product number that is printed on the label is  57512 And the Best By date is 06/01/23 (June 1, 2023). This infant formula was distributed in Michigan and … [Read more...]

FDA Developing New Framework For Expanded Access to Infant Formula

The FDA is developing a new framework for expanded access to infant formula options for parents and caregiver in the wake of the Abbott Nutrition plant shutdown after Cronobacter contamination was found this spring. In May 2022, the FDA issued guidance that the agency was going to temporarily exercise enforcement discretion on a case-by-case basis for some requirements to address this shortage. The FDA has prioritized review of requests from firms that can document the safety and nutritional adequacy of their products, can make the largest volume of product available, and can get their products onto shelves in this country quickly. The infant formula supply has dramatically increased in the weeks since that guidance was issued. Many infants and other people rely on infant formula … [Read more...]

FDA Investigating Another Infant Cronobacter Illness and Death

The FDA is investigating another infant Cronobacter illness and death, according to a news update about the issue of Abbott Nutrition's Cronobacter contamination problem. The news is contained at the end of the news release. The statement says that the FDA has reviewed and investigated a total of 129 complaints associated with Abbott Nutrition powdered infant formula products. Of these, 119 complaints were reported after the voluntary recall of Similac, Electra, and Aliments products on February 17, 2022. Nine of those complaints were of infant deaths. Only two were associated with the Abbott Nutrition Sturgis, Michigan plant investigation. The FDA states, "despite extensive investigation the evidence does not rule in or rule out a definitive link between these infant deaths and … [Read more...]

Senator Patty Murray Demands Accountability in Infant Formula Crisis

Senator Patty Murray (D-WA) is demanding accountability in the powdered infant formula crisis. After four infants were sickened with Cronobacter infections starting in September 2021, the FDA conducted an inspection at the Abbott Nutrition Sturgis, Michigan plant and found environmental contamination with that pathogen. The patient isolates did not match the environmental samples, but the plant was closed for weeks for cleaning and an investigation, triggering a shortage. Senator Murray is part of the HELP Committee, which is working on a bipartisan deal to respond to this crisis, as part of th FDA Safety and Landmark Advancements Act. Senator Murray said in a statement, "Families need accountability from FDA and formula manufacturers, and they desperately need formula—and I am … [Read more...]

DeLauro Concerned About Abbott Nutrition Facility Reopening

Congresswoman Rose DeLauro (D-CT) is concerned about the Abbott Nutrition facility reopening after Cronobacter contamination was found in the plant. In a press release, she states, "Following credible reports that Abbott Nutrition had falsified records, cut corners, and instituted substandard safety practices, the Sturgis, Michigan, facility reopened to begin manufacturing infant formula once again. Given that there is no transparency on the reopening process to the public, irresponsible is the only word that comes to mind." In testimony to Congress in late May 2022, FDA Commissioner Robert Califf said that inspectors had found "shocking" conditions in the plant and that it had "egregiously unsanitary" conditions. Califf added that an investigation could not conclude that those … [Read more...]

FDA Importing Specialized Medical Infant Formula to Increase Supply

The FDA is importing specialized medical infant formula to increase thee U.S. supply after the Abbott Nutrition plant in Sturgis, Michigan was closed when Cronobacter contamination was found. Cronobacter can cause serious and fatal infections in infants, especially those that are premature. The FDA says that millions of bottles of these formulas will be imported. FDA Commissioner Robert M. Califf, M.D. said in a statement, "We have made tremendous progress, including notable steps in just the past week, which will allow us to immediately begin bringing specialty and infant formula products into the U.S. as quickly as possible. We continue to work closely with our U.S. government partners and domestic and international manufacturers to identify additional formula product that will be … [Read more...]

FDA Updates Activities on Infant Formula Supply Challenges

The FDA has updated its activities on infant formula supply challenges. The agency is trying to increase the supply and availability of infant formula since the Abbott Nutrition plant in Sturgis, Michigan closed because the FDA found Cronobacter contamination in the environment. The agency warned parents not to use certain powdered infant formula products from that facility on February 17, 2022. A recall was issued by Abbott the same day. Cronobacter is a bacteria that can cause serious illness and death in infants, particularly premature babies and those with other medical conditions. A consent decree of permanent injunction was filed in the U.S. District Court for the Western District of Michigan on May 16, 2022. Abbott has agreed to take corrective actions following the FDA … [Read more...]

Abbott Enters Consent Decree With FDA To Reopen Infant Formula Plant

Abbott enters consent decree with the FDA to reopen their Sturgis, Michigan powdered infant formula plant that was closed after Cronobacter was discovered in the environment. The FDA inspection was prompted by reports of infant illnesses and deaths. The United States filed the decree on behalf of the FDA. It would require Abbott Nutrition to take "specific measures designed to increase safety and ensure compliance wi the Federal Food, Drug and Cosmetic Act" and the FDAs Good Manufacturing Practice requirements. Attorney General Merrick B. Garland said in a statement, "The actions we are announcing today will help to safely increase the supply of baby formula for families. The Justice Department will vigorously enforce the laws ensuring the safety of our food and other essential … [Read more...]

USDA Offers Tips to Keep Infants Safe While Formula Shortages Exist

The USDA offers tips to keep infants safe while powdered infant formula shortages are ongoing. The shortage is caused by pandemic supply chain issues and the closure of Abbott Nutrition's Sturgis, Michigan plant for environmental Cronobacter contamination. The contamination was discovered during an FDA inspection after reports of infant illnesses. Many parents depend on formula in the first year of a baby's life. Some mothers cannot breastfeed, and some infants require supplemental nutrition or specialty formulas because of medical issues. To keep infants safe, the USDA says parents should not make homemade infant formula. There are serious safety and health concerns related to homemade formula because they can be deficient in nutrients that babies need for health and growth. … [Read more...]

USDA Addresses Powdered Infant Formula Shortage

The USDA has announced that it is addressing the powdered infant formula shortage and is asking states to take advantage of flexibility in the WIC (Women Infants and Children) program. The shortage was caused by pandemic-related supply chain issues and by the closure of Abbott Nutrition's Sturgis, Michigan plant, where Cronobacter was found in environmental samples after complains of infant illnesses. Agriculture Secretary Tom Vilsack said in a statement, "We’re acutely aware that the ongoing recall has left many parents and caregivers concerned about access to formula and how they will feed their babies. Our team is committed to the health and safety of all Americans and is calling on states to act immediately to offer maximum flexibility, information, and support to WIC … [Read more...]

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