Category Archives: FDA

USA – FDA – Investigations of Foodborne Illness Outbreaks

Posted on November 28, 2024 by | Leave a comment

FDA

What’s New

  • A new outbreak of Salmonella Typhimurium (ref #1277) linked to a not yet identified product has been added to the table. FDA has initiated traceback.
  • For the outbreak of E. coli O157:H7 (ref #1269) linked to a not yet identified product, the case count has increased from 21 to 25 cases.
  • For the outbreak of E. coli O121:H19 (ref #1273) linked to organic whole and baby carrots supplied by Grimmway Farms, FDA has updated the outbreak advisory. FDA has also initiated an onsite inspection and sample collection.
  • For the outbreak of E. coli O26:H11 (ref #1272) linked to a not yet identified product, the outbreak has ended.

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Posted in CORE Investigation Table, E.coli O121, E.coli O157, E.coli O157:H7, E.coli O26, E.coli O26 :H11, FDA, food bourne outbreak, Food Illness, Foodborne Illness, foodborne outbreak, foodbourne outbreak, Illness, Salmonella, STEC E.coli O121

USA – FDA Enforcement Report – Pero Family Farms Squash Sliced Zucchinni & Yellow Squash – Listeria monocytogenes

Posted on November 28, 2024 by | Leave a comment

FDA

Pero Family Farms Squash Sliced Zucchinni & Yellow Squash, Net Wt. 11oz (311g) Plastic Tray, 4 trays per carton, Microwavable Tray, Keep Refrigerated. UPC 874896009764

F-0149-2025

Class II
Lot # 346918 Expiration Date: 10/28/2024

3149 cases

Squash products potentially contaminated with Listeria monocytogenes.

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Posted in FDA, FDA Enforcement Report, Listeria, Listeria monocytogenes

USA -FDA Warning Letter Rise N’ Shine Farm, Inc. Eggs – Salmonella

Posted on November 28, 2024 by | Leave a comment

FDA

Reference: CMS Case 672629

Dear Mr. Lawson:

The United States Food and Drug Administration (FDA) conducted an inspection of your shell egg farm and egg processing facility, where your eggs are washed and packed, located at 4307 Roland Hayes Parkway SW in Calhoun, Georgia, between October 23, 2023, and October 27, 2023. During our inspection, FDA investigators found serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs During Production, Storage, and Transportation regulation (the shell egg regulation), Title 21, Code of Federal Regulations, Part 118 (21 CFR 118), as well as sanitation concerns in your egg processing facility. Additionally, FDA collected environmental samples (i.e., swabs) from your farm and detected the presence of Salmonella Enteritidis (SE) as further described in this letter.

Based on FDA’s inspectional findings, we have determined that the shell eggs produced on your farm do not comply with the provisions of 21 CFR Part 118. Failure to comply with 21 CFR Part 118 causes your shell eggs to be in violation of section 361(a) of the Public Health Service Act (the PHS Act), 42 United States Code (U.S.C.) § 264(a). In addition, these violations and analytical findings render your shell eggs adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the FD&C Act, the PHS Act, and the shell egg regulation though links on FDA’s homepage at http://www.fda.gov.

At the conclusion of the inspection, FDA investigators issued you a Form FDA 483 (FDA-483), Inspectional Observations. You provided written responses to the inspectional findings dated November 10, 2023, December 4, 2023, December 12, 2023, and multiple updates throughout January 2024 describing additional corrective actions. We are issuing this letter to advise you of FDA‘s continued concerns based on the inspectional findings, sample and analytical results, and our review of your responses.

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Posted in FDA, FDA Warning Letter, Salmonella, Salmonella in Eggs

USA – Handsome Brook Farms Issues Recall of Kirkland Signature Organic Pasture Raised 24-Count Eggs Because of Possible Health Risk – Salmonella

Posted on November 28, 2024 by | Leave a comment

FDA

“Label Kirkland Signature Organic Eggs Pasture-Raised 24 Eggs Grade A Large UPC 9661910680”

New York, New York (November 27, 2024) Handsome Brook Farms is voluntarily recalling 10,800 retail units of the Organic Pasture Raised 24-Count Eggs sold under the Kirkland Signature brand name because these eggs have the potential to be contaminated with Salmonella, 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.

These units of the Kirkland Signature Organic Pasture Raised 24-Count Eggs were distributed into 25 Costco stores in the States of Alabama, Georgia, North Carolina, South Carolina, and Tennessee beginning November 22, 2024.

The Organic Pasture Raised 24-Count Eggs with UPC 9661910680 are packaged in plastic egg cartons labeled with Kirkland Signature on the top. The recall only applies to units with the Julian code 327 and a Use By Date of Jan 6, 2025, which can be found printed on the side of the plastic egg carton. No other products are impacted by this recall.

The recall was initiated after the company determined that eggs not intended for retail distribution were instead packaged and distributed in retail packaging. Additional supply chain controls and retraining are being put in place to prevent recurrence.

To date there are no illness complaints. This recall is being done in cooperation with the FDA.

Impacted consumers should stop consuming the product and should return the identified units to their local Costco store for a full refund or should dispose of the products. For those who have additional questions, please contact Handsome Brook Farms via phone at 646-733-4532, ext. 1, Monday through Friday, 9 AM – 6 PM EST or contact us at any time at recall@hbfeggs.com.

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Posted in FDA, food recall, product recall, Salmonella, Salmonella in Eggs

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USA – Squash product recalled because of potential Listeria contamination

Posted on November 27, 2024 by | Leave a comment

Food Safety News

Pero Family Farms Food Company LLC is recalling certain Pero Family Farms Squash Sliced Zucchini & Yellow Squash because the products are potentially contaminated with Listeria monocytogenes.

According to the Food and Drugs Administration (FDA), the recall was initiated on Nov. 5, 2024, and is ongoing.

The recalled products were distributed in Florida, Missouri, Illinois and Virginia.

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Posted in FDA, food recall, Listeria, Listeria monocytogenes, product recall, Recall

USA – Correction Notice: Canadian Food Inspection Agency Laboratory Error Incorrectly Resulted in Recall of Church Brothers Farms Green Onions – Recall Rescinded- no Salmonella

Posted on November 26, 2024 by | Leave a comment

FDA

Salinas, CA — November 25, 2024 – The Canadian Food Inspection Agency (CFIA) has determined that a laboratory error incorrectly caused the October 18, 2024 recall announcement concerning Church Brothers Farms’ Green Onions. The products from Church Brothers did not contain Salmonella and the recall has been rescinded.

On October 18, 2024 Church Brothers Farms voluntarily recalled 1271 cases of Green Onions due to the potential to be contaminated with Salmonella. This action was based on information received from the CFIA that a single product sample had tested positive for its presence. While distribution of this product was limited to a small number of retail and foodservice customers in Canada and USA, Church Brothers acted quickly and in conjunction with both the CFIA and US FDA to ensure rapid compliance with the recall.

Following the positive Salmonella result, the CFIA completed the whole genome sequencing (WGS) analysis of the Salmonella isolate, the results of which indicated that the sample could have been cross-contaminated with the laboratory’s positive control strain.

After further internal review, the CFIA conclusively determined that cross-contamination had indeed occurred. The CFIA also confirmed that the cross-contamination was an isolated event, and no other samples were affected.

Given this cross-contamination, the CFIA has rescinded the food recall and removed the notification that was published on the Government of Canada’s Recalls and Safety Alerts website.

“The safety of our products is Church Brothers’ highest priority, and we pride ourselves with having the utmost integrity when it comes to Food Safety Standards,” said Megan Chedwick, Vice President of Food Safety, Quality & Regulatory Compliance at Church Brothers Farms. “While we were pleased to hear that our product did not contain the Salmonella isolate, we will always act with an abundance of caution when it comes to the health and well-being of our consumers.”

This is a correction to the press release issued on October 18, 2024 with the headline of “Church Brothers Farms Recall Green Onions Due to Possible Health Risk.”

Company Contact Information
Church Brothers Farms
Consumer Hotline 877-590-0428
consumerinfo@churchbrothers.com

Link to Original Press Release

Company Contact Information

Consumers:
Church Brothers Farms Consumer Hotline
 877-590-0428
 consumerinfo@churchbrothers.com

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Posted in FDA, Salmonella

USA – Gaines Pet Treats LLC Voluntarily Recalls “Gaines Family Farmstead Chicken Chips for Dogs” Due to Possible Salmonella Contamination

Posted on November 24, 2024 by | Leave a comment

FDA

Gaines Pet Treats LLC, of Birmingham, AL is voluntarily recalling 204, 5-ounce bags of “Gaines Family Farmstead Chicken Chips” treats for dogs due to the possibility of Salmonella contamination.

Salmonella can affect animals eating the product and there is risk to humans from handling contaminated products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

The recalled “Gaines Family Farmstead Chicken Chips” were distributed through online retailers and into several small independent pet retailers in Alabama, Florida and Georgia.

The product comes in a 5-ounce bag marked on the back side with lot number 20061124 and an expiration date of 12/11/25.  This is the only lot number identified as potentially contaminated, no illnesses have been reported to date in connection with this problem and Gaines has made every effort possible to recover the potentially contaminated products.

The potential for contamination was noted after a third party tested and identified contamination in a related, unreleased lot of the same product.

Consumers who have purchased 5-ounce bags of “Gaines Family Farmstead Chicken Chips” stamped with lot 20061124, should cease using them and may contact Gaines at Recall@GainesFamilyFarmstead.com for an immediate refund or replacement.

Company Contact Information

Consumers:
Gaines
 Recall@GainesFamilyFarmstead.com

Product Photos

  • Gaines Family Farmstead Chicken Chips Dog Treats, 5 oz, front label
  • Gaines Family Farmstead Chicken Chips Dog Treats, back label

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Posted in FDA, Pet Food, Pet Food Recall, Pet Food Salmonella, Pet Food Testing

USA – Carolina Prime Pet, Inc. Recalls “Hollywood Feed Carolina Made Chicken Chips” Because of Possible Salmonella Health Risk

Posted on November 24, 2024 by | Leave a comment

FDA

Carolina Prime Pet, Inc. of Lenoir, NC, is recalling 400 16-ounce bags of “Hollywood Feed Carolina Made Chicken Chips” treats for dogs because they have the potential to be contaminated with Salmonella.  Salmonella can affect animals eating the product and there is risk to humans from handling contaminated products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

The recalled “Hollywood Feed Carolina Made Chicken Chips” were distributed to Hollywood Feed stores in Alabama, Arkansas, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Mississippi, Missouri, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, and Texas, and were also available through online retailer http://www.hollywoodfeed.com.

The product comes in a 16-ounce purple-and-black bag marked on the back side with lot number 20051324L2 and an expiration date of 11/13/25.  This is the only lot number identified as potentially contaminated.

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

The potential for contamination was noted after testing performed by a third-party laboratory identified contamination in a related yet commercially unreleased lot of the same product.

Consumers who have purchased 16-ounce bags of “Hollywood Feed Carolina Made Chicken Chips” stamped with lot 20051324L2 should cease using them.  Consumers may contact the company at treats@carolinaprimepet.com or 828-394-6460 Monday-Friday 8:00AM-4:00PM EST for information about returning recalled product for a refund or replacement product.

Product Photos

  • Hollywood Feed Carolina Made Chicken Chips, dog treats

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Posted in FDA, Pet Food, Pet Food Recall, Pet Food Salmonella, Pet Food Testing

USA – Investigations of Foodborne Illness Outbreaks

Posted on November 22, 2024 by | Leave a comment

FDA

What’s New

  • For the outbreak of E. coli O157:H7 (ref #1269) linked to a not yet identified product, the case count has increased from 18 to 21 cases.
  • For the outbreak of E. coli O121:H19 (ref #1273) linked to organic whole and baby carrots supplied by Grimmway Farms, FDA has issued an advisory. Grimmway Farms has initiated a voluntary recall of several sizes and brands of bagged, organic whole and baby carrots. See the outbreak advisory for additional information.
  • For the outbreak of Salmonella Liverpool (ref #1265) linked to a not yet identified product, the outbreak has ended.
  • For the investigation of illnesses (ref #1233) linked to Diamond Shruumz-brand Chocolate Bars, Cones, and Gummies, the advisory was updated on November 15, 2024. CORE’s investigation is complete, and the agency is now focused on post-incident actions and activities.

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Posted in E.coli O121, E.coli O157, E.coli O157:H7, FDA, Salmonella, STEC E.coli O121

USA – Fabalish Inc. Recalls “Kickin’ Carrot Falafel Bites” Because of Possible Health Risk -STEC E.coli O121

Posted on November 22, 2024 by | Leave a comment

FDA

Fabalish Inc, Carlstadt, NJ is recalling Kickin’ Carrot Falafel Bites because it may be contaminated with Shiga toxin-producing Escherichia coli (E. coli) O121:H19. E. coli O121:H19 is a bacterium that can cause serious and sometimes fatal infections in young children, elderly people, and those with a weakened immune system. Some infections can cause severe bloody diarrhea conditions, such as a hemolytic uremic syndrome, or the development of high blood pressure, chronic kidney disease, and neurologic problems. Symptoms include severe stomach cramps, diarrhea, fever, nausea, and/or vomiting. The incubation period for E. coli O121:H19 in humans can range from 24 hours to as much as ten days. The average incubation period is 3 to 4 days.

The product was distributed in FL, NY, WA, TN, CA, IN, OH, IL, NH, VA, GA, NE, CO, UT, KS, TX, MA & MT. These products were sold directly to consumers through the Fabalish website. www.fabalish.comExternal Link Disclaimer

This product comes in a 10 oz orange box and labeled as “Fabalish Kickin’ Carrot Falafel Bites” with the lot code 260925 found on the side flap. See images attached.

No illnesses have been reported to date.

This recall is being conducted in response to a nationwide recall initiated by Grimmway Farms of organic whole carrots, which has been identified as a potential risk by one of our suppliers. Grimmway Farms Recalls Organic Whole and Select Organic Baby Carrots That May Be in Consumers’ Homes Due to Potential E. coli Contamination | FDA

Consumers who have purchased the affected Fabalish Kickin’ Carrot Falafel Bites are urged to discard in the trash and send a photo to orders@fabalish for a full refund. Consumers with any questions may contact the company at (201) 942-2900 Monday to Friday 10AM to 3PM EST.

Company Contact Information

Consumers:
Fabalish Inc.
 201-942-2900

Product Photos

  • Fabalish Falafel Bites, Kickin’ Carrot, 12 pieces
  • Top package label showing LOT 260925

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Posted in E.coli O121, 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 Quality, food recall, Food Safety, Food Safety Alert, Food Safety Management, Food Safety Regulations, Food Testing, STEC, STEC E.coli, STEC E.coli O121