Category Archives: FDA

Germany – * Baby food * Similac, Alimentum and EleCare from the ABBOTT brand

LMW

Alert type: Food
Date of first publication: 03/25/2022
Product name:

* Baby food * Similac, Alimentum and EleCare from the ABBOTT brand

Product images:

image.jpg

BVL

Manufacturer (distributor): Abbott Nutrition in Sturgis, Michigan Country of origin: United States of America
Reason for warning:

Possible contamination with Salmonella Newport and Cronobacter sakazakii

Packaging Unit: 400 grams
Durability: from April 01, 2022
Lot identification: The first two digits of the lot number start with 22 to 37 AND the lot numbers contain the details K8, SH or Z2.
Further information:

Reference to a public warning from the US Food and Drug Administration:

Possible contamination of US infant formula with Cronobacter sakazakii and Salmonella Newport

Status 03/24/2022

The US Food and Drug Administration (FDA) warns against the use of certain powdered infant formulas manufactured by Abbott Nutrition in Sturgis, Michigan.

On February 17, 2022, Abbott announced that it had initiated a voluntary recall of certain lots of potentially affected products. The products in question are Similac, Alimentum and EleCare powdered food, which are manufactured at the plant in Sturgis, Michigan.

The recall is related to consumer complaints about Cronobacter sakazakii and Salmonella Newport infections in the United States. In all of these cases, infant formula from the manufacturer Abbott Nutrition is said to have been consumed. All five cases related to these ailments required hospitalization. In two cases, the infection may have contributed to the deaths of the patients.

The FDA is warning against the purchase and consumption of certain infant formulas manufactured at Abbott Nutrition’s Sturgis, Michigan facility.

The products were shipped within the USA and in member states of the EU (Italy, Ireland, Croatia, Netherlands, Slovenia, Spain) and other third countries (e.g. Great Britain, India, Islamic Republic of Iran, Northern Ireland, Russian Federation, Turkey, Ukraine, United States of America ) expelled. According to current knowledge, the products mentioned were not sold in Germany.

There is a possibility that consumers could have purchased the products online via marketplaces or through short-term stays in the Member States or third countries.

The FDA advises consumers not to use Similac, Alimentum, or EleCare powdered infant formula if:

  • the first two digits of the batch number begin with 22 to 37 and
  • the details K8, SH or Z2 are included and
  • a best-before date of April 1, 2022 is specified

The manufacturer offers the possibility to check the batch number of purchased products on the following page:  https://www.similacrecall.com/us/en/product-lookup.html

For more information on the FDA’s warning, please visit the following link: https://www.fda.gov/news-events/press-announcements/fda-warns-consumers-not-use-certain-powdered-infant-formula-produced- Abbott Nutrition Facility

The manufacturer’s recall can be found at the following link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-voluntarily-recalls-powder-formulas-manufactured-one-plant

For the warning in Turkish language, please refer to the following link: https://www.titck.gov.tr/duyuru/ilac-geri-cekme-24022022101035

Information on Salmonella and Cronobacter sakazakii

Salmonella  and  Cronobacter sakazakii  can cause illness in infants when present in powdered infant formula. Although Cronobacter sakazakii and Salmonella cannot grow in powdered infant formula, they can survive for a long period of time and therefore pose a potential risk after liquid addition if the product is not heated sufficiently during preparation. Contamination of infant formula powder with Cronobacter sakazakiiand salmonella can cause serious illnesses in infants, such as diarrhea (sometimes bloody), fever, sepsis or meningitis, which can cause serious neurological and developmental problems and, in rare cases, can be fatal. Sepsis and meningitis can present with poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), and abnormal breathing and movements. Among infants, newborns (<28 days), especially preterm, low birth weight, or immunocompromised infants are most at risk of becoming infected.

(Unofficial translation of the information at: https://www.fsai.ie/news_centre/food_alerts/Similac.html )

Further information on salmonella, also in other languages, can be found here: http://www.infectionsschutz.de/erregersteckbriefe/salmonellen

USA – FDA Core Investigation Table Update

FDA

Date
Posted
REF Pathogen
Total
Case Count

Status
3/16/

2022

1055 Salmonella
Saintpaul
Not Yet
Identified
60 Active
2/17/

2022

1056 Cronobacter
sakazakii
Powdered
Infant
Formula
See
Advisory
Active
2/9/

2022

1040 Listeria
monocytogenes
Not Yet
Identified
16 Active
2/2/

2022

1054 Enteroinvasive
E. coli
O143:H26
Not
Identified
16 Closed
1/10/

2022

1050 E. coli
O121:H19
Romaine 4 Closed
12/29/

2021

1052 E. coli
O157:H7
Packaged
Salad
See Outbreak
Advisory
Closed
12/20/2

021

1039 Listeria
monocytogenes
Packaged
Salad
See Outbreak
Advisory
Closed
12/15/2021 1048 Listeria
monocytogenes
Packaged
Salad
See Outbreak
Advisory
Active

USA – WISETRADE CORPORATION RECALLS ENOKI MUSHROOMS BECAUSE OF POSSIBLE HEALTH RISK – Listeria monocytogenes

FDA

1st image: “Global Fresh Marketing, Enoki Mushrooms, 200 g/7.05 oz”

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Food & Beverages
Produce
Foodborne Illness
Reason for Announcement:
Listeria monocytogenes contamination
Company Name:
WiseTrade Corporation
Brand Name:
Global Fresh Marketing
Product Description:
Enoki Mushrooms

Company Announcement

March 23, 2022, WiseTrade Corporation of Irvine, CA is recalling all its cases of its 200g/7.05oz packages of ENOKI MUSHROOM (Product of Korea) because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The recalled Enoki Mushroom product was distributed in CA to produce distributors or wholesalers for further distribution to retail stores.

The Enoki Mushroom comes in a 200g/7.05oz clear plastic package with the following description “Global Fresh Marketing Enoki Mushrooms” in the front and back Wisetrade Coporation Irvine, CA 92618.

The UPC is 809728-95012 on the back side of the package.

There is no lot code or dates on a package.

No illnesses have been reported to date in connection with this problem. The distribution of the product has been suspended.

The potential for contamination was discovered after a retail sample collected and analyzed by California Department of Public Health (CDPH) and revealed the presence of Listeria monocytogenes in 7.05 oz. package of Enoki mushroom.

This recall is being made with the knowledge of the U.S. Food and Drug Administration and CDPH.

Consumers who have purchased 200g packages of Enoki are urged to return them to the place of purchase for a full refund. Consumers with question may contact the company at 949-264-2268 Monday – Friday 7:00am – 3:00pm PST.


Company Contact Information

Consumers:
 949-264-2268

USA – Farm Fresh Produce LLC Recalls “TWA Agriculture Mixed Mushrooms” Because of Possible Health Risk

FDA

“Twa Mushroom, Mixed Mushroom, 14.11 oz”

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Food & Beverages
Produce
Foodborne Illness
Reason for Announcement:
Listeria monocytogenes contamination
Company Name:
Farm Fresh Product LLC
Brand Name:
TWA
Product Description:
Agriculture mixed mushrooms

Company Announcement

Farm Fresh Produce LLC of Vernon, CA, is recalling all of the 14.11 ounce packages of “TWA AGRICULTURE MIXED MUSHROOMS” because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The recalled ” TWA AGRICULTURE MIXED MUSHROOMS ” were distributed nationwide in retail store.

The product comes in a 14.11 ounce, clear plastic package marked with UPC6957937481850.

No illnesses have been reported to date in connection with this problem.

The potential for contamination was noted after routine testing by the California Department of Public Health (CDPH) revealed the presence of Listeria monocytogenes in 14.11 ounce packages of ” TWA AGRICULTURE MIXED MUSHROOMS.”

The production of the product has been suspended while FDA and the company continue to investigate the source of the problem.

Consumers who have purchased 14.11  ounce packages of ” TWA AGRICULTURE MIXED MUSHROOMS.”” are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-323-583-1128 ( Monday – Friday 6:00am – 1:30pm).


Company Contact Information

Consumers:
Jay Lam
 1-323-583-1128

USA – Microbiological Surveillance Sampling: FY17–19 Processed Avocado and Guacamole

FDA

The U.S. Food and Drug Administration collected and tested processed avocado, the main ingredient in guacamole, and finished guacamole as part of the agency’s proactive and preventive approach to deploying its sampling resources with the ultimate goal of preventing contaminated food from reaching consumers.

Assignment Overview

The assignment began in November 2017 and ended in September 2019. In total, the FDA collected and tested 887 samples of processed avocado and guacamole (domestic and imported product) for Salmonella spp. and Listeria monocytogenes. This total is smaller than the initial number of samples the agency set out to collect and test because the agency encountered factors that twice required a reduction of the collection target, as explained in the Sample Collection section of this report (page 6).

As to the design of the assignment, the FDA directed its field staff not to collect products that had undergone high-pressure processing (HPP) or products intended for HPP. HPP is a “kill step” validated to eliminate pathogenic microorganisms in food, and it is often used in the manufacture of processed avocado and guacamole. In seeking to exclude from the assignment products that had been HPP-treated, the FDA’s intent was to focus on products that posed the greatest risk to consumers.

The agency learned during its evaluation of the test results that some of the products collected had received HPP treatment but were not labeled as such. FDA staff worked retrospectively with industry to identify the HPP-treatment status of the samples collected but could not determine the status of a number of samples. Those samples were designated as “could not ascertain” for purposes of the data analysis.

Findings and Follow-up Actions

The FDA detected Salmonella spp.in two samples which were later determined to be distinct samples of the same brand of domestically manufactured guacamole from different lots. Neither sample had received HPP treatment. In addition, the agency detected Listeria monocytogenes in 15 samples from nine different firms. Of those 15 samples, eight had not been HPP treated. The HPP-treatment status of the other seven samples could not be ascertained.

When the FDA detected a pathogen in a domestic sample, agency personnel worked with the company that owned or distributed the affected product to conduct a voluntary recall in all cases in which product was available, or likely to still be available, to consumers. The FDA also conducted one follow-up inspection of a domestic facility, and state officials in Florida likewise conducted one domestic inspection. As to the imported samples, the agency refused to admit lots associated with the positives and placed the responsible companies on import alert. In all, the agency placed two firms on import alert. In addition, the agency conducted whole genome sequencing (WGS) analysis on the positives but was unable to determine whether processed avocado or guacamole were the food vehicle associated with any known human illnesses.

In addition to affirming that Salmonella spp. and Listeria monocytogenes may be present in processed avocado and/or guacamole, the assignment data show that the estimated prevalence of these pathogens in the non-HPP-treated samples was higher than in the HPP-treated samples. This finding appears to support other research that shows HPP is effective at neutralizing pathogenic microorganisms,[1] even as this assignment was not designed to compare possible differences based on HPP-treatment status. The findings also underscore the need for processors and others in the processed avocado and guacamole supply chain to comply with the FDA’s Preventive Controls for Human Food Rule[2] and for importers of these foods to comply with the FDA’s Foreign Supplier Verification Programs Rule.[3]


USA – FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022) – The problem is more than two years old.

FDA

If you want to check if your powdered formula is part of the recall, you can enter the product lot code on the bottom of your package on the company’s websiteExternal Link Disclaimer.

If you have questions or need information about the recall, you can Submit Questions/Get Assistance.

If your infant is experiencing symptoms related to Cronobacter infection, such as poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements; contact your health care provider to report their symptoms and receive immediate care.

To report an illness or adverse event, you can

The FDA, along with CDC and state and local partners are investigating consumer complaints and/or reports of infant illness related to products from Abbott Nutrition’s Sturgis, MI facility. All of the ill patients are reported to have consumed powdered infant formula produced from Abbott Nutrition’s Sturgis, MI facility.

The FDA is releasing the FDA Form 483s from three inspections conducted at Abbott Nutrition’s facility on Sept. 16-24, 2019Sept. 20-24, 2021, and Jan. 31-March 18, 2022. The inspectional observations in these Form 483s do not constitute final FDA determinations of whether any condition was or is in violation of the Federal Food, Drug, and Cosmetic Act or any of its implementing regulations. FDA will take appropriate action in the future – if warranted – as we continue to evaluate the 2022 inspectional findings.

Important observations noted in the 2022 Form 483 include, but are not limited to:

  • [Abbott Nutrition] did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment.
  • [Abbott Nutrition] did not ensure that all surfaces that contacted infant formula were maintained to protect infant formula from being contaminated by any source.

Once the immediate public health risk is minimized, FDA will conduct a programmatic review to ensure the maximum effectiveness of agency programs and policies related to infant formula and special medical food complaints, illnesses, and recalls.

Conducting this review is a top priority for the FDA and will be done as efficiently as possible, and we can ensure this effort will not interfere with the immediate recall response activities. We will and must continue focusing on taking all steps possible to protect the health of those who rely on safe powdered infant formula.

Recommendation

The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. Recalled products can be identified by the 7 to 9 digit code and expiration date on the bottom of the package (see image below). Products are included in the recall if they have all three items below:

  • the first two digits of the code are 22 through 37 and
  • the code on the container contains K8, SH, or Z2, and
  • the expiration date is 4-1-2022 (APR 2022) or later.

In addition to products described above, Abbott Nutrition has recalled Similac PM 60/40 with a lot code 27032K80 (can) / 27032K800 (case). At this time, Similac PM 60/40 with lot code 27032K80 (can) / 27032K800 (case) is the only type and lot of this specialty formula being recalled. Additional recall information for the initial recall is available on the FDA website. Parents can also enter their product lot code on the company’s websiteExternal Link Disclaimer to check if it is part of the recall.

Additional information for parents and caregivers of infants receiving medical specialty infant formulas and individuals using certain medical foods is available below.

Additional Information for Parents and Caregivers:

The recalls do not include liquid formula products.

Parents and caregivers should never dilute infant formula and should not make or feed homemade infant formula to infants. Consumers should also avoid purchasing imported formula through online sales, as it has the potential to be counterfeit.

If your regular formula is not available, contact your child’s healthcare provider for recommendations on changing feeding practices.

If you get infant formula through WIC, do not throw the formula out. Instead, you should take it to the store for a refund and exchange or call the company at 1-800-986-8540 to help you. WIC recipients should be able to obtain a different brand of similar formula. Call your local WIC clinic for more guidance. Also see:

More information on Cronobacter and infant formula is available on CDC’s website.

Recalled powdered infant formulas have the potential to be contaminated with Cronobacter, a bacterium that can cause severe foodborne illness primarily in infants. Cronobacter infections are rare but are especially high risk for newborn infants (see symptoms below).

Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine). Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths, and abnormal body movements. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body.

If your child is experiencing any of these symptoms, you should notify your child’s healthcare provider and seek medical care for your child immediately. Healthcare providers and health departments are encouraged to report any confirmed cases of Cronobacter sakazakii to CDC.


Product Images

Sample Product Image from the FDA Investigation of Cronobacter and Salmonella Complaints about Powdered Infant Formula (February 2022)
Sample Product Image from the FDA Investigation of Cronobacter and Salmonella Complaints about Powdered Infant Formula (February 2022)
Sample Product Image from the FDA Investigation of Cronobacter and Salmonella Complaints about Powdered Infant Formula (February 2022)

Case Counts

Total Adverse Events: 4
Hospitalizations: 4
Reported Deaths: 2*
Illness Onset Date Range: 9/6/2021 – 1/4/2022
States with Adverse Events: MN (1), OH (2), TX (1)
Product Distribution: Nationwide and International
* Two deaths have been reported. Cronobacter infection may have contributed to the cause of death for both patients.

USA – FDA issues warning to New Mexico onion importer linked to Salmonella outbreak

Food Safety News

An import company in New Mexico is on notice from the FDA for not having food safety documents for a number of imported foods. The inspection was initiated because of an investigation of a multistate foodborne outbreak of Salmonella Oranienburg illnesses linked to whole, fresh onions imported from the state of Chihuahua, Mexico.

The outbreak has sickened more than 800 people in the United States and remains under investigation. The Centers for Disease and Prevention has not yet declared the outbreak over.

In its warning letter the Food and Drug Administration  acknowledged that the company initiated a voluntary recall on Oct. 22, 2021, of red, yellow, and white onions imported from its “suppliers (redacted)” in Chihuahua, Mexico, from July 1, 2021, through Aug. 25, 2021.

In the March 2, 2022, warning letter just made public by the FDA, the agency described a Nov. 16, 2021, Foreign Supplier Verification Program (FSVP) inspection of Keeler Family Farms in DemingNM.

USA – T Fresh Company Recalls Enoki Mushrooms Because of Possible Health Risk

FDA

Front label, 150g Yes! Enoki Mushrooms Front label, 200g Yes! Enoki Mushrooms

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Food & Beverages
Reason for Announcement:
Listeria monocytogenes
Company Name:
T Fresh Company
Brand Name:
Yes!
Product Description:
Enoki Mushrooms

Company Announcement

T Fresh Company of City of Industry, CA is recalling its 5.25oz (150g) enoki mushrooms, Lot #6021053 grown in China & 7.5oz (200g) Lot # 6021052 grown in China, because it has the potential to be contaminated with listeria monocytogenes, a bacterium which can cause life-threatening illness.

Symptoms of listeria may include fever, muscle aches, severe headache, nausea, vomiting, stiff neck, confusion, loss of balance, and convulsions. People experiencing these problems should seek immediate medical attention. This bacteria can be completely destroyed and the risk of infection can be eliminated by thoroughly cooking foods at temperatures of 165°F (73.8°C).

Lot #6021053 was distributed from California and Texas to retail stores through produce distributors, while traces of the bacterium were discovered by CDPH sampling. Product is packaged in a pink and transparent plastic packaging, with the “Yes” Logo for the 150g(5.25oz) & Light Blue & transparent plastic packaging, with ” Yes” Logo for the 200g(7.5oz). Enoki mushrooms are white, stringy with small caps. The weight of the product is 5.25 oz (150g) & 7.5 oz (200g). The UPC barcode numbers are 825382736718 (150g), with no other codes & 825382736947 (200g), with no other codes.

The distribution of the product has been suspended. No infections or illnesses have been reported or confirmed. Consumers who have purchased our enoki mushrooms are urged to return it to the place of purchase for a full refund bought within the dates January 18th, 2022 to Feb 16th, 2022 for both items. Consumers with questions may contact the company at 626-968-2088 Monday to Friday, 9am to 3pm PST.

Mushrooms are fungi, meaning they are not vegetables or fruits. Consumers should never eat mushrooms raw. All surfaces, utensils or containers that are used for preparing mushrooms should be separated from other foods to avoid cross-contamination.


Company Contact Information

Consumers:
T Fresh Company
 626-968-2088

USA – Mystery Salmonella and Listeria Outbreaks sicken 75 in United States while infant formula kills 2

Food Poison Journal

The Food and Drug Administration has posted an increase in the number of patients in an outbreak of Listeria monocytogenes infections as it continues investigations into three other outbreaks.

The new patient count in the Listeria outbreak is 16, up from 14 reported a week ago. As of March 16 the FDA had not determined the cause of the outbreak. The agency has initiated traceback efforts, but has not revealed what food or foods are involved in those activities.

The FDA has not revealed any demographic information on the Listeria patients and has not reported where they live.

In other outbreak news the FDA is investigating a new outbreak of Salmonella SaintPaul infections that has sickened 59 people. The agency announced the outbreak on March 16. As with the Listeria outbreak investigation, the FDA has not released any patient information for the Salmonella outbreak and has not reported where the patients live. Traceback efforts have begun, according to the FDA, but the agency did not report what food or foods are involved.

USA – Core Investigation Table Update – Salmonella Saintpaul Outbreak

FDA

The FDA has launched a Traceback Investigation to identify the source of the outbreak. 59 cases have been reported so far, no Public Health Advisory has been issued yet. Salmonella Saintpaul has been identified as the strain causing the illnesses.

Date
Posted
Ref Pathogen
Product
Linked to
Illnesses

(if any)
Case Count
Status
3/16/

2022

1055 Salmonella
Saintpaul
Not Yet
Identified
59 Active
2/17/

2022

1056 Cronobacter
sakazakii
Powdered
Infant
Formula
See
Advisory
Active
2/9/

2022

1040 Listeria
monocytogenes
Not Yet
Identified
16 Active
2/2/

2022

1054 Enteroinvasive
E. coli
O143:H26
Not
Identified
16 Closed
1/10/

2022

1050 E. coli
O121:H19
Romaine 4 Closed
12/29/

2021

1052 E. coli
O157:H7
Packaged
Salad
See Outbreak
Advisory
Closed
12/20/

2021

1039 Listeria
monocytogenes
Packaged
Salad
See Outbreak
Advisory
Closed
12/15/2021 1048 Listeria
monocytogenes
Packaged
Salad
See Outbreak
Advisory
Active