Category Archives: FDA

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

Posted on January 16, 2023 by | Leave a comment

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

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Posted in FDA, food contamination, food handler, Food Hazard, Food Hygiene, Food Inspections, Food Micro Blog, Food Microbiology, Food Microbiology Blog, Food Microbiology Testing, Food Pathogen, food recall, Food Safety, Food Safety Alert, Food Safety Management, Food Safety Regulations, Food Testing, Listeria, Listeria monocytogenes

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

Posted on January 13, 2023 by | Leave a comment

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

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Posted in Biotoxin, FDA, Food Microbiology, Food Microbiology Blog, Food Microbiology Research, Food Microbiology Testing, Histamine, Marine Biotoxin, microbial contamination, Microbial growth, Microbiological Risk Assessment, Microbiology, Microbiology Investigations, Microbiology Risk, Scombroid, scombroid poisoning, Toxin

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

Posted on January 12, 2023 by | Leave a comment

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.

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Posted in FDA, food contamination, food handler, Food Hazard, Food Hygiene, Food Inspections, Food Micro Blog, Food Microbiology, Food Microbiology Blog, Food Microbiology Testing, Food Pathogen, Food Poisoning, food recall, Food Safety, Food Safety Alert, Food Safety Management, Food Safety Regulations, Food Testing, Food Toxin, STEC, STEC E.coli

USA -FDA – Investigations of Foodborne Illness Outbreaks

Posted on January 5, 2023 by | Leave a comment

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.

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Posted in Decontamination Microbial, FDA, food bourne outbreak, Food Micro Blog, Food Microbiology, Food Microbiology Blog, Food Microbiology Testing, foodborne outbreak, foodbourne outbreak, microbial contamination, Microbial growth, Microbiological Risk Assessment, Microbiology, Microbiology Investigations, Microbiology Risk, outbreak, Salmonella, Sprouting Seeds

USA – SunSprout Enterprises Voluntarily Expands Recall to Four Lots of Alfalfa Sprouts Due to Potential Contamination with Salmonella

Posted on December 30, 2022 by | Leave a comment

FDA

Image 2 - SunSprouts Alfalfa Sprouts, Front Clamshell

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Food & Beverages
Produce
Foodborne Illness
Reason for Announcement:
Salmonella
Company Name:
SunSprout Enterprises
Brand Name:
Sun Sprouts
Product Description:
Alfalfa Sprouts

Company Announcement

Fremont, Nebraska, December 29, 2022 – SunSprout Enterprises is voluntarily recalling four lots (#4211, 5211, 3212, and 4212) of raw alfalfa sprouts in 4-ounce clamshells and 2.5lb packages, with best by dates between 12/10/22 and 1/7/23, due to potential contamination with Salmonella.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The company directly distributed 1406 pounds of product to five foodservice and grocery customers in Nebraska, Kansas, and Iowa between late November and mid December 2022. No other SunSprout lot codes or products are impacted by this voluntary recall.

The raw alfalfa sprouts are packaged in 4-ounce clamshells and 2.5lb packages with best sold buy dates between 12/10/2022 and 1/7/2023 and lot codes #4211, 5211, 3212, and 4212. The best sold buy date can be found on the front of the package. The alfalfa sprouts are available in the produce section of grocery stores.  To date, SunSprout has received no complaints or reports of illness due to this recalled product. This voluntary recall is a result of a preliminary investigation by the State of Nebraska in connection with CDC of an outbreak of illness likely associated with alfalfa sprouts. SunSprout, out of an abundance of caution, is initiating this voluntary recall while it further investigates how this alfalfa product was handled and stored after it left its Nebraska facility.

Customers with product from this lot number in their possession should stop using it and dispose of it immediately. Consumers are also encouraged to follow all safe handling instructions and wash their hands and all preparation surfaces after handling any raw product. If consumers have any questions, they can contact SunSprout by email at Admin@sunsprouts.com anytime, responses will be provided Monday–Friday, 8:00 a.m. through 5:00 p.m. CST.

This recall is being conducted in cooperation with the U.S. Food and Drug Administration.  Photographs of the product label are below for ease of confirmation.

Link to Initial Recall.

Company Contact Information

Consumers:
Mike Rhodes
 402-331-0803
 Admin@sunsprouts.com

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Posted in FDA, food contamination, food handler, Food Hazard, Food Hygiene, Food Inspections, Food Micro Blog, Food Microbiology, Food Microbiology Blog, Food Microbiology Testing, Food Pathogen, food recall, Food Safety, Food Safety Alert, Food Safety Management, Food Safety Regulations, Food Testing, Salmonella

USA – Caesar’s Pasta, LLC Recalls Frozen Manicotti Because of Possible Health Risk – Listeria monocytogenes

Posted on December 30, 2022 by | Leave a comment

FDA

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Food & Beverages
Reason for Announcement:
Listeria monocytogenes
Company Name:
Caesar’s Pasta, LLC
Brand Name:
Caesar’s Pasta & Orefresco
Product Description:
Frozen manicotti

Company Announcement

Caesar’s Pasta, LLC of Blackwood, NJ is recalling 5,610 lbs. of frozen manicotti, 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.

Frozen manicotti was sold to various foodservice distributors, distributing to restaurants in the Philadelphia, PA; Harrisburg, PA; Southeastern NY State; Northeastern PA; and San Juan, PR markets. Product did NOT enter retail commerce.

Frozen manicotti was packaged in 10 lb. bulk boxes under the brand names Orefresco and Caesar’s Pasta with a “Best By” date of September 28, 2024.

No illnesses have been reported to date.

The product is categorized as “Not-Ready-To-Eat” and cooking instructions on the product label clearly state that product must be cooked to 160 degrees, which would effectively kill the bacteria.

The recall was the result of a routine sampling program, which revealed that the finished products may contain the bacteria. The FDA and the company continue their investigation as to what may have caused the problem.

Each of the company’s customers who received the affected product have been notified and have been provided with instructions to discard the product.

Company Contact Information

Consumers:
Caesar’s Pasta, LLC
 856-227-2585 Ext 226

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Posted in FDA, food contamination, food handler, Food Hazard, Food Hygiene, Food Inspections, Food Micro Blog, Food Microbiology, Food Microbiology Blog, Food Microbiology Testing, Food Pathogen, food recall, Food Safety, Food Safety Alert, Food Safety Management, Food Safety Regulations, Food Testing, foodborne outbreak, Listeria, Listeria monocytogenes

USA – SunSprout Enterprises Voluntarily Recalls Two Lots of Alfalfa Sprouts Due to Potential Contamination with Salmonella

Posted on December 30, 2022 by | Leave a comment

FDA

Image 1 – SunSprouts Alfalfa Sprouts, Back Clamshell

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Food & Beverages
Produce
Foodborne Illness
Reason for Announcement:
Salmonella
Company Name:
SunSprout Enterprises
Brand Name:
Sun Sprouts
Product Description:
Alfalfa Sprouts

Company Announcement

Fremont, Nebraska, December 28, 2022 – SunSprout Enterprises is voluntarily recalling two lots (#4211 and 5211) of raw alfalfa sprouts in 4-ounce clamshells, with best by dates between 12/10/22 and 12/27/22, due to potential contamination with Salmonella.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The company directly distributed 808 pounds of product to five foodservice and grocery customers in Nebraska, Kansas, and Iowa between late November and early December 2022. No other SunSprout lot codes or products are impacted by this voluntary recall.

The raw alfalfa sprouts are packaged in 4-ounce clamshells with best buy dates between 12/10/2022 and 12/27/2022 and lot codes #4211 and 5211. The lot code and best buy date can be found on the front of the package. The alfalfa sprouts are available in the produce section of grocery stores.  To date, SunSprout has received no complaints or reports of illness due to this recalled product. This voluntary recall is a result of a preliminary investigation by the State of Nebraska in connection with CDC of an outbreak of illness likely associated with alfalfa sprouts. SunSprout, out of an abundance of caution, is initiating this voluntary recall while it further investigates how this alfalfa product was handled and stored after it left its Nebraska facility.

Customers with product from this lot number in  their possession should stop using it and dispose of it immediately. Consumers are also encouraged to follow all safe handling instructions and wash their hands and all preparation surfaces after handling any raw product. If consumers have any questions, they can contact SunSprout by email at Admin@sunsprouts.com anytime, responses will be provided Monday–Friday, 8:00 a.m. through 5:00 p.m. CST.

This recall is being conducted in cooperation with the U.S. Food and Drug Administration.  Photographs of the product label are below for ease of confirmation.

Link to Expanded Recall.

Company Contact Information

Consumers:
Mike Rhodes
 402-331-0803
 Admin@sunsprouts.com

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Posted in FDA, food contamination, food handler, Food Hazard, Food Hygiene, Food Inspections, Food Micro Blog, Food Microbiology, Food Microbiology Blog, Food Microbiology Testing, Food Pathogen, food recall, Food Safety, Food Safety Alert, Food Safety Management, Food Safety Regulations, Food Testing, Food Toxin, Salmonella

USA – FDA Warning Letter – Bainbridge Beverage West, LLC- Microbial Risk

Posted on December 29, 2022 by | Leave a comment

FDA

The U.S Food and Drug Administration (FDA) inspected your juice manufacturing facility, located at 2335 Del Monte Street, West Sacramento, CA 95691 on June 9, 10, 22, 24, and 29, 2022. We found that you have serious violations of the FDA’s juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR Part 120). In accordance with 21 CFR 120.9, failure of a processor to have and implement a HACCP plan that complies with the requirements of 21 CFR Part 120 renders the juice products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)]. Accordingly, your juice products are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act, FDA’s juice HACCP regulations and the Juice HACCP Hazards and Controls Guidance through links in FDA’s home page at www.fda.gov.External Link Disclaimer

To date, the agency has not received a written response from your firm regarding the violations noted on the Form FDA-483, Inspectional Observations, which was issued to your firm at the conclusion of the inspection.

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Posted in Decontamination Microbial, FDA, Food Micro Blog, Food Microbiology, Food Microbiology Blog, Food Microbiology Research, Food Microbiology Testing, HACCP, Hepatitis A, microbial contamination, Microbial growth, Microbiological Risk Assessment, Microbiology, Microbiology Investigations, Microbiology Risk

FDA – Core Outbreak Table Updates – Investigations of Foodborne Illness Outbreaks

Posted on December 29, 2022 by | Leave a comment

FDA

What’s New

  • A multistate outbreak of Salmonella Typhimurium (reference #1137) has been added to the table. The Nebraska Department of Health and Human Services and the Nebraska Department of Agriculture issued an advisory regarding illnesses in their state. Preliminary information gathered by state partners indicates that patients consumed alfalfa sprouts prior to becoming ill. FDA’s investigation is underway to confirm the product causing illnesses and additional information will be provided when it becomes available.

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Posted in FDA, food bourne outbreak, Food Illness, Foodborne Illness, foodborne outbreak, foodbourne outbreak, Illness, outbreak, Salmonella

USA – Food Code 2022

Posted on December 29, 2022 by | Leave a comment

FDA

Food Code 2022

The Food Code is a model for safeguarding public health and ensuring food is unadulterated and honestly presented when offered to the consumer. It represents FDA’s best advice for a uniform system of provisions that address the safety and protection of food offered at retail and in food service.

This model is offered for adoption by local, state, and federal governmental jurisdictions for administration by the various departments, agencies, bureaus, divisions, and other units within each jurisdiction that have been delegated compliance responsibilities for food service, retail food stores, or food vending operations. Alternatives that offer an equivalent level of public health protection to ensure that food at retail and foodservice is safe are recognized in this model.

The 2022 Food Code (10th edition) reflects the agency’s continued commitment to maintaining cooperative programs with state, local, tribal, and territorial governments.

The 2022 edition reflects the input of regulatory officials, industry, academia, and consumers that participated in the 2020 biennial meeting of the Conference for Food Protection (CFP) (held in 2021).

Members of FDA’s National Retail Food Team are available to assist regulatory officials, educators, and the industry in their efforts to adopt, implement, and understand the provisions of the FDA Food Code and the Retail Program Standards. Inquiries may be sent to retailfoodprotectionteam@fda.hhs.gov or directly to a Retail Food Specialist located in one of FDA’s three Retail Food Protection Branches across the country.

Food Code 2022 (PDF: 4.68MB)

Summary of Changes in the 2022 FDA Food Code

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Posted in Decontamination Microbial, FDA, Food Micro Blog, Food Microbiology, Food Microbiology Blog, Food Microbiology Research, Food Microbiology Testing, Food Safety, Food Safety Management, Food Safety Regulations, food safety training, microbial contamination, Microbial growth, Microbiological Risk Assessment, Microbiology, Microbiology Investigations, Microbiology Risk