Analysis Contrary to its own operating procedures, Abbott Nutrition completed an internal probe of a fatal Cronobacter case without testing samples of the associated lot of Similac Pro Total Comfort, according to the FDA's 2022 inspection report of Abbott's facility in Sturgis, MI. Federal health officials have been investigating four Cronobacter illnesses, two of them fatal, reported between September 2021 and January 2022 among infants who consumed Similac products made at Abbott's Sturgis plant. Yesterday, the U.S. Food and Drug Administration (FDA) released the reports from its three most recent inspections of the Sturgis facility. The reports show that Abbott failed to maintain sanitary conditions at the plant where it makes a variety of infant formulas including some for babies … [Read more...]
New Salmonella Saint Paul Outbreak on FDA’s CORE Table
A new Salmonella Saintpaul outbreak has been listed on the FDA's CORE Outbreak Investigation Table. According to the table, there are at least 59 people sick in this particular outbreak. According to the table, traceback has been initiated, but no recall has been ordered, no on-site inspection has begun, and there has been no sample collection or analysis. The FDA does not provide much information about an outbreak unless there are actions that consumers can take. This is a fairly rare strain of Salmonella. In 2013, a Salmonella Saintpaul outbreak that was linked to imported cucumbers sickened at least 84 people in 18 states. Seventeen people were hospitalized because they were so sick. And a Salmonella Saintpaul outbreak in Michigan in 2017 sickened at least 15 people. A … [Read more...]
Timeline: Chronobacter Illnesses Linked to Infant Formula
The CDC, FDA, and state health departments are investigating Cronobacter illnesses among infants who consumed powdered baby formula. Between September 2021 and January 2022, four illnesses were reported -one from Minnesota, two from Ohio, and one from Texas. The two babies in Ohio died. Cronobacter is not a “reportable disease” nationwide. So, doctors and labs aren’t required to report these infections to their state health departments who then report them to the Centers for Disease Control and Prevention (CDC). Minnesota is the only state in the country that requires reporting. The CDC does receive reports of Cronobacter, an average of three a year. It's just not required. So unlike illnesses from E. coli, Salmonella, or Listeria, the genetic fingerprint of the Cronobacter that made … [Read more...]
FDA Updates the Recalled Cronobacter Infant Formula Product List
The FDA has updated the recalled Cronobacter infant formula list with a full list of recalled products. In addition, they say that metabolic and other medical specialty infant formulas were produced at the same plant which made the recalled Similac PM 60/40, but those products were not recalled "because the FDA has determined that the risk of not having these specialty products available could significantly worsen underlying medical conditions. For many of these patients, the risk of life-threatening adverse events from restricted access to these critically needed products is likely greater than the risk from consuming products that have been produced at the facility." So far, at least four infants, who lived in Minnesota, Texas, and Ohio, have been diagnosed with Cronobacter … [Read more...]
Similac Recall Includes Formula Made November 2020 to February 2022
Abbott Nutrition's recall of powdered infant formula includes Similac products made at the company's facility in Sturgis, MI over the 15-month period from November 1, 2020, to February 17, 2022, according to recall information the company provided to retailers. Because these dates are not mentioned in the company's public recall announcement, consumers may not be aware that formula they purchased for their infants more than a year ago is part of this recall. The length of the production window associated with the recall also raises questions about the results of the FDA's inspection of the plant. Abbott issued a recall for Similac, Alimentum, EleCare, and EleCare Jr on February 17, 2022, after the U.S. Food and Drug Administration (FDA) announced an investigation of … [Read more...]
DeLauro Wants an Investigation into FDA Handling of Infant Formula Recall
Rep. DeLauro wants an investigation into the FDA handling of infant formula monitoring and recalls, more specifically the Abbott Nutrition powdered infant formula recall associated with at least four Cronobacter illnesses. Rosa Delauro (D-CT) is the chair of the House Appropriations Committee. A letter was sent to the Inspector General of the Department of Health and Human Services, asking for her assistance in this investigation. DeLauro states, "Based on reports, I am concerned the agency acted too slowly in pulling potentially dangerous infant formula off store shelves, which may have resulted in additional illnesses and death. The delay between the September inspection and the recall raises serious questions about the FDA’s ability to adequately regulate the infant formula … [Read more...]
Expanded Similac Recall For Cronobacter Complaints Posted
The expanded Similac recall for Cronobacter complaints has been posted on the FDA recall page. At least four infants have been diagnosed with Cronobacter infections after consuming Similac, EleCare, or Alimentum powdered infant formula with specific lot numbers and expiration dates that were produced at Abbott Nutrition's Sturgis, Michigan plant. Two of those infants who lived in Ohio died, although the FDA is investigating to see if Cronobacter contributed to those deaths. The expanded Similac recall for Cronobacter complaints is for Similac PM 60/40 with lot number 27032K80 for the can and 27032K800 for the case. This recall is in addition to the lots of Similac, Alimentum, and EleCare powdered formula that were voluntarily recalled on February 17, 2022. This new recall was … [Read more...]
Cronobacter Complications: Necrotizing Enterocolitis, Sepsis, and Meningitis
Cronobacter complications can include necrotizing enterocolitis (NEC), sepsis, and meningitis. These conditions can be fatal for infants, and a worry for parents in light of the Cronobacter illnesses linked to powdered infant formula. What are the symptoms of these conditions and what should parents look for? Four Infants Sick with Cronobacter First, some background. The Centers for Disease Control and Prevention (CDC) states that there are four infants from Minnesota, Texas, and Ohio who were sickened with Cronobacter infections after they were allegedly fed powdered infant formula produced by Abbott Nutrition at their Sturgis, Michigan plant. More reports of illness are being investigated. A recall has been issued for four types of that formula: Similac Pro Total Comfort, … [Read more...]
CDC Cronobacter Investigation Widens, 2 Ohio Infants Dead
In a typical year, between two to four cases of Cronobacter are reported to the Centers for Disease Control and Prevention (CDC). But a current federal investigation that already includes two deaths in Ohio and two illnesses in Texas and Minnesota among infants who consumed Similac powdered infant formula has widened, according to the CDC. After the U.S. Food and Drug Administration (FDA) announced its collaborative investigation with the CDC and state partners of Cronobacter illnesses, and one Salmonella illness, in Ohio, Minnesota, and Texas, the CDC received additional reports of possible Cronobacter illnesses and another Salmonella illness. The agency is using whole genome sequencing tests to sort things out, Brian Katzowitz, a CDC spokesman, told Food Poisoning Bulletin this … [Read more...]
FDA Advice For Parents About Infant Formula Cronobacter Illnesses
This FDA advice for parents about infant formula and the Cronobacter illnesses linked to some types of powdered formula is offered to help parens navigate this difficult time. At least four infants, from Minnesota, Ohio, and Texas, are sick with Cronobacter sakazakii infections after consuming recalled Similac, EleCare, or Alimentum formula produced at Abbott Nutrition's Sturgis, Michigan plant. Because infant formula is the sole source of nutrition for many newborns and infants, the FDA is offering help. The FDA is stating that one infant allegedly contracted a Salmonella infection after being fed this formula, but the CDC is not including this illness in the case count until they complete their investigation. The key to the recall is the lot codes and expiration date on the … [Read more...]
