Category Archives: FDA

USA – Outbreak Investigation of Listeria monocytogenes: Enoki Mushrooms (November 2022)

FDA

FDA, along with CDC and state and local partners, is investigating an outbreak of Listeria monocytogenes infections linked to enoki mushrooms. FDA has identified enoki mushrooms distributed by Utopia Foods, Inc. of Glendale, New York and imported from China, and enoki mushrooms labeled as “Producer: Shandong Youhe Biotechnology, Co.,” with an address in China and “Distributed By: Sun Hong Foods, Inc.” as likely sources of illnesses in this outbreak. Enoki mushrooms are long thin white mushrooms, usually sold in clusters. They are especially popular in East Asian cuisine and are also known as enokitake, golden needle, futu, seafood, or lily mushrooms.

As of January 18, 2022, CDC reports three illnesses included in this outbreak. Through ongoing import and product sampling of enoki mushrooms, two strains of Listeria monocytogenes detected on enoki mushroom products have been determined through Whole Genome Sequencing (WGS) to be the same strains of Listeria monocytogenes linked to illnesses in this outbreak. Both strains are included in this outbreak investigation.

On January 17, 2023, FDA reported a positive import sample of enoki mushrooms that matched both outbreak strains and resulted in a voluntary recall expansion from Utopia Foods, Inc. Additional sample collection and analysis conducted by the Maryland Department of Health have also identified both outbreak strains of Listeria monocytogenes in two product samples of enoki mushrooms. These products that tested positive are sold in a 7.05-oz (200g) clear plastic package with a brown and green label and include a label on the back of the package that states: “Producer: Shandong Youhe Biotechnology Co.,” with an address in China, and “Distributed By: Sun Hong Foods, Inc.”

On December 17, 2022, FDA issued a safety alert for enoki mushrooms labeled as “Producer: Shandong Youhe Biotechnology, Co.,” with an address in China and “Distributed By: Sun Hong Foods, Inc.,” as a result of a positive product sample collected by Missouri state partners. At that time, these products were not linked to an active outbreak. The strain of Listeria found in these products matches one of the two strains linked to illnesses in this outbreak. FDA’s safety alert has been updated with the most recent information linking these products to an ongoing outbreak investigation.

FDA’s investigation is ongoing to determine a potential source of contamination and whether any other products are contaminated or linked to illnesses. Additional information will be provided as it becomes available.

Recommendation

Consumers, restaurants, and retailers should not eat, sell, or serve recalled enoki mushrooms from Utopia Foods, Inc. and enoki mushrooms labeled as “Producer: Shandong Youhe Biotechnology, Co.,” with an address in China and “Distributed By: Sun Hong Foods, Inc.” Consumers should check the label on both the front and the back of their enoki mushroom package to view distributor information (see photos below).

Listeria is especially harmful if you are pregnant, aged 65 or older, or have a weakened immune system due to certain medical conditions or treatments. If you are in any of these groups, do not eat any raw enoki mushrooms. For enoki mushrooms that are not recalled or potentially contaminated, always cook enoki mushrooms thoroughly to kill any foodborne germs.

Call your healthcare provider right away if you have any of these symptoms after eating enoki mushrooms:

  • People who are not pregnant usually have fever, muscle aches, and tiredness. They may also get a headache, stiff neck, confusion, loss of balance, or seizures.
  • Pregnant people usually have fever, muscle aches, and tiredness. However, Listeria can cause pregnancy loss or premature birth. It can also cause serious illness or death in newborns.

Follow FDA’s safe handling and cleaning advice and use extra vigilance in cleaning and sanitizing any surfaces and containers that may have come in contact with these recalled products to reduce the risk of cross-contamination, including retailers who stored or repackaged recalled enoki mushrooms. Listeria can survive in refrigerated temperatures and can easily spread to other foods and surfaces.

USA – FDA – Warning Letter – Gold Coast Distributors Inc. dba Shah Distributors

FDA

The United States Food and Drug Administration (FDA) inspected your ambient and frozen warehouse and re-packing facility, located at 2325 W. Charter Way, Stockton, CA 95206, from May 09-27, 2022. During our inspection of your facility, the FDA investigators observed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). At the conclusion of the inspection, the FDA investigators issued a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your firm. In addition, during the inspection, FDA collected filth samples from various areas within your warehouse facility, and the analytical results revealed rodent, insect, or cat filth present all throughout your facility.

USA – FDA Core Investigation Update

FDA

There are no new outbreaks this week but two are still active.

12/28/2022 1137 Salmonella
Typhimurium
Alfalfa Sprouts See
Outbreak
Advisory
11/9/2022 1127 Listeria
monocytogenes
Enoki
Mushrooms
See
Outbreak
Advisory

USA – Fullei Fresh Issues Correction on Alfalfa Sprout Recall Because of Possible Health Risk – Listeria monocytogenes

FDA

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Food & Beverages
Spices, Flavors &  Salts
Foodborne Illness
Reason for Announcement:
Contamination with shiga toxin-producing E. coli
Company Name:
Fullei Fresh
Brand Name:
Fullei Fresh
Product Description:
Alfalfa Sprouts

Company Announcement

MIAMI, FL – Fullei Fresh is voluntarily recalling Alfalfa Sprouts due to the detection of Shiga toxin producing E.coli (STEC.) Shiga toxin producing E.coli is an organism that can cause foodborne illness in a person who eats a food item contaminated with it. Symptoms of infection may include stomach cramps, diarrhea, and vomiting. The illness primarily impacts elderly individuals, children, and people with weakened immune systems. Most healthy adults and children rarely become seriously ill.

STEC is a bacterial strain that is not part of our routine microbial testing conducted in compliance with the FDA’s Produce Safety Rule Subpart M on every lot we produce. It was detected upon sampling of finished product by the FDA.

There have been no known illnesses reported to date in connection with this product.

The affected Fullei Fresh brand alfalfa sprout lot number is 336. They were shipped to distributors and retailers in Florida between December 9-23, 2022. No other lots or products are affected.

The lot numbers are printed on the 4 ounce retail packs and on 5 lb. bulk cardboard boxes in the barcode (the last 3 digits being 336.) Pictures are below.

Should you be in possession of these products, please discard.

This recall is being made with the knowledge of the Food and Drug Administration and the Florida Department of Agriculture.

If you require further information, please contact sales@fulleifresh.com or (305) 758-3880 Monday through Friday between 8:00 AM and 4:00PM EST.


Company Contact Information

Consumers:
 305-758-3880
 sales@fulleifresh.com

Product Photos

USA -FDA – Core Investigation Table – Investigations of Foodborne Illness Outbreaks

FDA

What’s New

  • An outbreak advisory has been issued for the outbreak of Listeria monocytogenes linked to enoki mushrooms (reference #1127).

USA – Fullei Fresh Issues Correction on Alfalfa Sprout Recall Because of Possible Health Risk STEC E.coli

FDA

Alfalfa Sprouts Clamshell with Label

MIAMI, FL – Fullei Fresh is voluntarily recalling Alfalfa Sprouts due to the detection of Shiga toxin producing E.coli (STEC.) Shiga toxin producing E.coli is an organism that can cause foodborne illness in a person who eats a food item contaminated with it. Symptoms of infection may include stomach cramps, diarrhea, and vomiting. The illness primarily impacts elderly individuals, children, and people with weakened immune systems. Most healthy adults and children rarely become seriously ill.

STEC is a bacterial strain that is not part of our routine microbial testing conducted in compliance with the FDA’s Produce Safety Rule Subpart M on every lot we produce. It was detected upon sampling of finished product by the FDA.

There have been no known illnesses reported to date in connection with this product.

The affected Fullei Fresh brand alfalfa sprout lot number is 336. They were shipped to distributors and retailers in Florida between December 9-23, 2022. No other lots or products are affected.

The lot numbers are printed on the 8 ounce retail packs and on 5 lb. bulk cardboard boxes in the barcode (the last 3 digits being 336.) Pictures are attached.

Should you be in possession of these products, please discard.

This recall is being made with the knowledge of the Food and Drug Administration and the Florida Department of Agriculture.

If you require further information, please contact sales@fulleifresh.com or (305) 758-3880 Monday through Friday between 8:00 AM and 4:00PM EST.


Company Contact Information

Consumers:
 305-758-3880
 sales@fulleifresh.com

USA – Utopia Foods Expands Recall on “Enoki Mushrooms” Because of Possible Health Risk – Listeria monocytogenes

FDA

Front of package, Utopia Foods Enoki Mushrooms

Company Announcement

Utopia Foods Inc of Glendale, NY, is expanding the recall of its 200g packages of “Enoki Mushrooms”, imported from China, with clear and blue plastic packages with clear markings of “Best before 03/02/2023” or “Best before 03.09.23” distributed between January 6th to January 13th, 2023 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 product comes in a 200g, clear and blue plastic package with brand name “UTOPIA” and bar code 8928918610017 marked on the packaging.

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

The recalled “Enoki Mushrooms” were distributed in NY, NJ and CT to produce wholesale companies.

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

All vendors who have distributed the 200g packages of “Enoki Mushrooms” should immediately cease the distribution and notify their customers of the recall and recall instructions. If their customers have further distributed the product notify them to instruct their customers.

Consumers who have purchased the item are urged to return them to the place of purchase for a refund.

Consumers with questions may contact the company at 718.389.8898.


Company Contact Information

Consumers:
Utopia Foods Inc
 718.389.8898

USA – Investigated Illnesses and Outbreaks Table Update for Seafood Related Natural Toxin and Scombrotoxin Fish Poisoning

FDA

January 12, 2023

Table 1: Closed Illness and Outbreak Incidents is a list of investigations that were managed by FDA’s Seafood-Related Natural Toxin and Scombrotoxin Fish Poisoning Team for Fish Other Than Molluscan Shellfish. The listed incidents have been completed at this time.

The table is managed and updated when a significant number of illnesses have been investigated in a specific period of time or at least quarterly.

The table has been updated to illustrate additional information such as

  • Pending analytical results;
  • Confirmed fish/fishery product species identifications; and
  • Completed analytical results are listed in their own column.

The following FDA tracking numbers, and illness type have been added to the table:

  • 20-09-08: CFP;
  • 22-08-15: SFP;
  • 22-08-17: SFP;
  • 22-09-18: SFP;
  • 22-09-20: CFP/SFP;
  • 22-10-21: Unknown;
  • 22-11-22: SFP; and
  • 22-12-23: SFP.

The table may be found at: How to Report Seafood-Related Toxin and Scombrotoxin Fish Poisoning Illnesses | FDA

USA – Fullei Fresh Recalls Alfalfa Sprouts Because of Possible Health Risk – STEC E.coli –

FDA

Alfalfa Sprouts Clamshell with Label

MIAMI, FL – Fullei Fresh is voluntarily recalling Alfalfa Sprouts due to the detection of Shiga toxin producing E.coli (STEC.) It is a strain of e.coli which is not part of their routine e.coli O157:H7 and salmonella testing which is normally conducted on every lot produced. There have been no known illnesses reported to date in connection with this product.

The affected Fullei Fresh brand alfalfa sprout lot number is 336. They were shipped to distributors and retailers in Florida between December 9-23, 2022. No other lots or products are affected.

The lot numbers are printed on the 8 ounce retail packs and on 5 lb. bulk cardboard boxes in the barcode (the last 3 digits being 336.) Pictures are attached.

Should you be in possession of these products, please discard.

USA -FDA – Investigations of Foodborne Illness Outbreaks

FDA

What’s New

  • On December 30, 2022, FDA issued an advisory for the outbreak Salmonella Typhimurium (reference #1137) linked to alfalfa sprouts. SunSprout Enterprises issued a voluntary recall on December 29, 2022 and later expanded their recall on the same day. FDA has also initiated traceback, an on-site inspection, and sample collection and analysis.
  • There are no other updates to this week’s table.