May 24, 2022

FDA: Abbott Didn’t Test Similac Samples in Internal Probe of Infant Death

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...]

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...]

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...]

Same E. coli Strain Linked to 4 Outbreaks and 8 Deaths 2018- 2021

This week, the CDC announced the end of a deadly leafy greens E. coli outbreak. And revealed that it was caused by the same strain as the deadly outbreak linked to romaine lettuce grown in Yuma, AZ in 2018. This is the fourth multistate outbreak linked to this E. coli O157:H7 strain since 2018. All of them have included at least one fatality. Two of them occurred in 2021. Together these four outbreaks resulted in 274 illnesses, 126 hospitalizations, 33 cases of a type of kidney failure called hemolytic uremic syndrome (HUS), and eight deaths. Leafy greens were identified as the source of two of the outbreaks. For the other two, which occurred in 2020 and 2021, the source was declared as "unknown." Like the 2018 outbreak, some of the greens linked to the outbreak that ended this … [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...]

Minnesota Cronobacter Case Spurred Federal Investigation

In St. Louis County, MN, which encompasses the central and eastern portions of the Iron Range as it stretches from Duluth to the Canadian border, the leaves were reaching peak color when one of its newest and tiniest residents fell gravely ill. It was September 2021. The baby had developed a Cronobacter infection and would spend 22 days in the hospital successfully fighting it off. But because Minnesota is the only state in the nation that requires reporting of Cronobacter, which is known to cause severe, often fatal, infections in infants, that was not the end of the story. Reportable or notifiable diseases are considered to be of such great public health importance that when they are diagnosed they must be reported to state health officials who, in turn, report them to the … [Read more...]

The Long, Sad History of Cronobacter and Baby Formula

If you're lucky, the first time you ever heard the word "Cronobacter" was on a news segment last week. The foodborne pathogen with a name that sounds like a sci-fi villain doesn't make headlines often. And that's good. Because Cronobacter is only known for one thing - causing severe, often fatal, illness in newborn babies. And its main vehicle of transmission is powdered infant formula. Last week, federal health officials announced that they are investigating a possible link between Similac, EleCare, and Alimentum powdered baby formulas and the illnesses of four infants who consumed them. Three of the infants, in Minnesota, Ohio, and Texas, developed Cronobacter infections. One of them, another infant in Texas, developed a Salmonella infection. All four of the babies were … [Read more...]

Recalled Baby Formula Still on Store Shelves

A major baby formula recall for Similac, EleCare, and Alimentum was issued five days ago, so why are these products still on store shelves? On Friday, February 17, Abbott Nutrition issued a baby formula recall for Similac, Alimentum, and EleCare after four illnesses were reported among infants who consumed them. The Cronobacter and Salmonella illnesses were reported from three states, MN (1), OH (1), and TX (2). All four babies were hospitalized and Cronobacter may have contributed to a death in one case, according to the U.S. Food and Drug Administration (FDA). After Food Poisoning Bulletin received reports that consumers were still finding recalled baby formula on store shelves, we went out this morning and took a look ourselves. Five days after the recall, we found recalled … [Read more...]

FDA Boosts Outreach Amid Baby Formula Cronobacter Concerns

As concerned parents scramble for information in the wake of a Cronobacter baby formula recall, the FDA is amplifying the methods consumers can use to ask questions or submit complaints. On Friday, the U.S. Food and Drug Administration (FDA) issued a consumer advisory about Similac, EleCare, and Alimentum baby formulas made at Abbott Nutrition’s Sturgis, MI facility. The advisory was prompted by three reports of Cronobacter sakazakii infections and one report of a Salmonella Newport infection in infants who had consumed these products.  All four infants were hospitalized and Cronobacter may have contributed to a death in one case, according to the FDA. “As this is a product used as the sole source of nutrition for many of our nation’s newborns and infants, the FDA is deeply concerned … [Read more...]

Similac, Alimentum and EleCare Baby Formula Recall

Abbott Nutrition has issued a baby formula recall for Similac, Alimentum, and EleCare after four illnesses were reported among infants who consumed them. The Cronobacter and Salmonella illnesses were reported from three states, MN (1), OH (1), TX (2). between September 6, 2021, and December 18, 2021 Three of the infants developed Cronobacter sakazakii infections and one of them contracted a Salmonella Newport infection. All were hospitalized and Cronobacter may have contributed to a death in one case, according to the U.S. Food and Drug Administration (FDA). Cronobacter illnesses are rare but can be deadly for newborns because they can cause sepsis and meningitis, according to the Centers for Disease Control and Prevention (CDC). For infants, symptoms of sepsis or meningitis include … [Read more...]

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