The FDA updates CORE Outbreak Investigation Table. More illnesses have been added to two mystery Salmonella outbreaks and one mystery Listeria monocytogenes outbreak. And a new "adverse event series" that is associated with a "frozen food product," has been added. That product is not identified, but it is most likely the Daily Harvest French Lentil + Leeks Crumble product, which is associated with almost 500 adverse events and has been recalled. There are currently 10 active outbreak investigations. The frozen food outbreak has 107 adverse event reports listed. A recall has been issued, traceback has begun, an on-site inspection has been conducted, and sample collections have been analyzed. Yesterday Fresh Harvest issued a statement saying that the FDA testing has found no pathogens … [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...]
Similac Infant Formula Recalled in Canada For Possible Cronobacter
Similac Infant Formula is being recalled in Canada for possible Cronobacter and Salmonella contamination. This recall was triggered by a consumer complaint, although no illnesses have been reported in Canada in connection with this problem. Shoppers Drug Mart is issuing the recall, since these products were recalled on February 17, 2022 and some units were sold online in error. The recalling firm is Abbott Nutrition. The recalled products are all powdered infant formula. They include Similac Advance Step 1 Milk-Based Iron-Fortified Infant Formula Powder sold in 964 gram packages. The UPC number is 0 55325 00163 8 and the codes are L28174SH0 and L36099SH0. Also recalled is Similac Advance Step 2 Milk-Based Iron-Fortified and Calcium-Enriched Infant Formula Powder, also sold in 964 … [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...]
New E. coli O157:H7 Outbreak Added to FDA CORE Investigation Table
A new E. coli O157:H7 outbreak has been added to the FDA's CORE Outbreak Investigation Table. At least 10 people are sick. We do not know the states where the ill persons live, their age range, illness onset dates, or if anyone has been hospitalized. Traceback has been initiated, but no recall has been issued, there has been no on-site inspection or sample collection, and no analysis of any product has started. This new E. coli O157:H7 outbreak is probably associated with an FDA-regulated food. This outbreak joins four other active outbreak investigations, and the investigation into the Cronobacter illnesses and Abbott Nutrition's powdered infant formula plant closure has been transferred to an IMG investigative unit. The hepatitis A outbreak linked to imported FreshKampo and HEB … [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...]
FDA Closes Listeria and Norovirus Outbreak Investigations
The FDA closes Listeria and norovirus outbreak investigations on its CORE Outbreak Investigation Table, while the alleged cereal outbreak case count increased. There are now only three active food poisoning outbreak investigations being conducted by the FDA. The Listeria monocytogenes outbreak that closed has sickened at least 20 people. A vehicle was not identified, even though traceback was initiated, an on-site inspection was initiated, and samples were collected and analyzed. The outbreak status is still listed as "ongoing" because the most recent illness onset date was April 20, 2022. It can take up to 70 days for the symptoms of listeriosis to manifest. The CDC will continue to monitor for more illnesses. This investigation will be reopened if more new illnesses are reported … [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...]
