Lyons Magnus expands recall of nutritional and beverage products because of potential microbial contamination. That recall was issued on August 1, 2022 and included 53 different products. The recall is issued because the products may be contaminated with Clostridium botulinum and Cronobacter sakazakii. Root cause analysis found that the products did not meet commercial sterility specifications. Clostridium botulinum, the pathogen that causes botulism poisoning, has not been found in products, but consumers are warned not to consume these items even if they do not look or smell spoiled. The botulism toxin will not change the appearance, taste, texture, or smell of food. Vulnerable and immunocompromised people may be more susceptible to infection from Cronobacter bacteria. … [Read more...]
Lyons Magnus Recalls 53 Nutritional Products For Contamination
Lyons Magnus is recalling 53 nutritional and beverage products for possible microbial contamination, including Cronobacter sakazakii. This pathogen is most serious and can cause illness and death in infants. The list of recalled products does not include products that are intended for infants under the age of one. The recaling firm is Lyons Magnus LLC of Fresno, California. Infection related to Cronobacter is rare, but people can get sick from it. The most common symptoms include fever, vomiting, and urinary tract infections. No illnesses related to the consumption of these products has been reported to the company to date. Preliminary root cause analysis indicates that these products did not meet commercial sterility specifications. These products are packaged in various formats … [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 Updates CORE Outbreak Table; More Illnesses Added
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...]
