FDA Advisory Issued for Clams Harvested from Unapproved Waters

FDA issued an advisory about not consuming Red’s Best chopped clams that were likely harvested from prohibited waters in MA on 11/25/2023 and 11/26/2023.  Clams harvested from prohibited waters may be contaminated with human pathogens, toxic elements or poisonous or deleterious substances and can cause illness if consumed. Clams are filter feeders that remove and bioaccumulate bacteria and other pathogens from the water. It is not uncommon for shellfish to be consumed raw and whole. 

https://www.fda.gov/food/alerts-advisories-safety-information/fda-advises-restaurants-and-retailers-not-serve-or-sell-and-consumers-not-eat-certain-chopped-clams
FDA Advises Restaurants and Retailers Not to Serve or Sell and Consumers Not to Eat Certain Chopped Clams Likely Harvested from a Prohibited Area in Massachusetts and Distributed by Red’s Best

Salmonella-in-Diced-Onion Outbreak Over, Investigation Finds Salmonella at Farm

CDC declared the Salmonella outbreak associated with diced onions is now over. The onion product produced in August by Gill Onions of Oxnard CA, has cased 80 illnesses with 18 hospitalizations and 1 death. The product was recalled in October.

 "FDA collected multiple water, environmental, and product samples from the farm that supplied the contaminated onions to Gills Onions. Six of the samples, three water and three environmental, were positive for Salmonella spp. Whole Genome Sequencing (WGS) analysis confirmed that the strain of Salmonella found in isolates associated with three of the samples matched the same strain of Salmonella causing illnesses in this outbreak. Additional Salmonella isolates from the samples were detected, and CDC identified people who got sick with these strains of Salmonella. FDA and CDC partners reviewed the available data; however, there was not enough epidemiologic or traceback evidence to implicate a product or source of contamination for those illnesses."

Case Counts
Total Illnesses: 80
Hospitalizations: 18
Deaths: 1
Last Illness Onset: November 11, 2023
States with Cases: AZ, CA, CO, GA, ID, IL, IN, IA, KY, MA, MI, MT, NY, ND, OH, OR, TN, TX, UT, VA, WA, WI, WY
Foodservice Product Distribution*: Nationwide and Canada
Retail Product Distribution*: AZ, CA, ID, MT, OR, WA

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-onions-october-2023
Outbreak Investigation of Salmonella: Onions (October 2023)
FDA’s Investigation is complete. CDC declares outbreak over.
Current Update
December 13, 2023

WA State Establishment Recalls Beef Soup After Plant-based Chicken Label Applied

USDA FSIS issued a public health alert for ready-to-eat (RTE) product labeled as birria-inspired beef soup due to misbranding and an undeclared allergen due to mislabeling issue. The product labeled as birria-inspired beef soup may actually contain plant-based chicken noodle soup, which contains sesame,  an allergen, which is not declared on the product label.  The issue was discovered by the retailer after a store employee identified a case of RTE Plant-Based Chicken Noodle Soup product bearing the correct top label but incorrect front and back labels. 

Strange that Plant-Based Chicken Noodle Soup contains no chicken.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-beef-soup-product-due-misbranding-and-undeclared
FSIS Issues Public Health Alert for Beef Soup Product due to Misbranding and Undeclared Allergen

FRESH FOODS OF WASHINGTON LLC

Iowa Firm Recalls Candies for Undeclared Egg Allergens

Valley View Candies of Edgewood, IA is recalling All Fudge products - Peanut Butter Fudge, Maple Nut Fudge, Chocolate Fudge, Chocolate Walnut Fudge, because it may contain undeclared eggs.  The recall was initiated after it was discovered that the fudge products containing egg was distributed in packaging that did not reveal the presence of egg.   

The issue appears to be the fact that the recalled products all contain marshmallow cream, an item which will normally contains egg whites as an ingredient.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/valley-view-candies-issues-allergy-alert-undeclared-egg-fudge-products
Valley View Candies Issues an Allergy Alert on Undeclared Egg in Fudge Products
Summary
Company Announcement Date:  December 14, 2023
FDA Publish Date:  December 14, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared eggs
Company Name:  Valley View Candies
Brand Name:  Valley View Candies
Product Description:  Peanut Butter, Maple Nut, Chocolate, and Chocolate Walnut Fudge

Colorado Company Recalls Product Due to Undeclared Allergens Again

Bobo’s of Loveland, Colorado is issuing a voluntary recall of Bobo’s Peach Oat Bars because they may contain undeclared coconut.   The recall was initiated after it was discovered that product containing coconut was distributed in packaging that did not reveal the presence of coconut on the ingredient deck.

This is not the first boo-boo for Bobo's involving incorrect packaging leading to a allergen-related recall.  In 2021, there were two recalls, one for peanuts in Maple Pecan Bars, and the other was peanuts in Almond Butter Bars.  The well developed and implemented Allergen Preventive Control would ensure that labeling errors such as this not occur.

Bobo’s Issues a Voluntary Allergy Alert on Undeclared Coconut in Product
Summary
Company Announcement Date: December 09, 2023
FDA Publish Date:  December 12, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared coconut.
Company Name:  Bobo’s
Brand Name:  Bobo’s
Product Description:  Peach Oat Bars

Ill Dairy Recalls Non-Egg Egg Nog, Holiday Nog, for Containing Egg

Prairie Farms Dairy, Inc. of Edwardsville, ILL has initiated a voluntary recall on specific batches of private label Holiday Nog purchased in United Dairy Farmers stores between December 4th through December 6th, 2023, that may contain an undeclared egg allergen.  This specific batch may have been mis-labeled related to egg allergens

Prairie Farms Dairy, Inc. of Edwardsville, ILL has Initiated a Voluntary Recall on Specific Batches of Private Label Holiday Nog Purchased in United Dairy Farmers Stores Between December 4th Through December 6th, 2023, that May Contain an Undeclared Egg Allergen
Summary
Company Announcement Date:  December 08, 2023
FDA Publish Date:  December 08, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared egg
Company Name:  Prairie Farms Dairy, Inc
Brand Name:  United Dairy Farmers
Product Description:  Holiday nog

FDA Warning Letter Highlights the Requirement for Reporting Non-compliant Product to Reportable Food Registry

In December of 2022, a feed facility of Nutra Blend, LLC subsidiary of Land O’Lakes., mistakenly added drug ingredient into a non-medicated feed which resulted in deaths of multiple calves. While FDA cited the company for issues with its Preventive Controls Plan, FDA also hit on the company for failing to report the non-compliant product into the Reportable Food Registry.  And this is an important regulation that may not be well known or can be overlooked.

What is the Reportable Food Registry?

• "The Reportable Food Registry (RFR or the Registry) is an electronic portal for Industry to report when there is reasonable probability that an article of food will cause serious adverse health consequences. The Registry helps the FDA better protect the public health by tracking patterns and targeting inspections." 
• Registered Food Facilities that manufacture, process, pack, or hold food for human or animal consumption ...are required to report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals.
• Must provide amended reports as necessary- for example, FDA understands that it may take more than 24 hours to perform investigation activities and obtain information such as the results of any investigation of the root cause of the adulteration (when applicable) and the disposition of the reportable food.
• Portal - https://www.safetyreporting.hhs.gov/SRP2/en/Home.aspx?sid=938fc413-86cd-4670-8fe4-64e25d253c33

In this case, the company knew there was an issue, but fumbled around trying to determine how bad the issue was rather then getting notification out.  

"Furthermore, you failed to report a reportable food to the Reportable Food Registry (RFR) within twenty-four hours of determining that it is reportable (i.e., that there is a reasonable probability that the use of, or exposure to, such animal food will cause serious adverse health consequences or death to animals).5 Failure to submit a required reportable food report is a prohibited act."

"You tried to justify not filing an RFR while you asked the lab to reanalyze and provide the actual amount of monensin present in the sample and continued to assess with your nutritionists, veterinarians, and published data if the elevated level of ionophores would result in an animal health issue. However, this feed was not formulated to contain any monensin (an ionophore) and you were already aware the animals appeared to have died of ionophore toxicity."

As for the improper mixing issues:

Your root cause investigation found the source of the monensin to be the weighed and staged (b)(4) of monensin intended for the next product, Accuration Finisher 44 R227. Your mixing operator occasionally combines (b)(4) from (b)(4) pallets onto a single pallet to minimize time spent moving the ingredients to the mixer. In this instance, you determined the operator combined (b)(4) from the (b)(4) different work orders, then removed all the barcode tags from all staged (b)(4) and placed them near the scanner so they would be accessible when he was ready to scan them. This action left all the micro-ingredients for (b)(4) products unidentified, causing the operator to erroneously add the monensin to the incorrect product. 

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nutra-blend-llc-subsidiary-land-olakes-651174-05222023
Nutra Blend, LLC subsidiary of Land O’Lakes
MARCS-CMS 651174 — MAY 22, 2023

Alabama Establishment Recalls RTE Chicken Products After Complaints for Being Undercooked

Wayne Farms, LLC, a Decatur, Ala. establishment, is recalling approximately 1,377 pounds of ready-to-eat (RTE) chicken breast products that may be undercooked.  The problem was discovered when the firm received a customer complaint that the RTE chicken product appeared to be undercooked.  There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an illness should contact a healthcare provider.

https://www.fsis.usda.gov/recalls-alerts/wayne-farms-llc-recalls-ready-eat-chicken-breast-products-may-be-undercooked-0
Wayne Farms, LLC, Recalls Ready-to-Eat Chicken Breast Products That May Be Undercooked

WASHINGTON, Dec. 7, 2023 – Wayne Farms, LLC, a Decatur, Ala. establishment, is recalling approximately 1,377 pounds of ready-to-eat (RTE) chicken breast products that may be undercooked, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Missouri Company Recalls Frozen Pizza for Undeclared Wheat Allergens

Shakespeare’s Pizza of Columbia, Missouri is recalling all its frozen pizzas from grocery stores, as they contain wheat, but do not declare the presence of wheat on their labels. A routine inspection by the  government regulatory agency partners brought to light the omission of a declaration on our labeling of the presence of wheat in the pizzas.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/shakespeares-pizza-issues-allergy-alert-concerning-undeclared-wheat-its-frozen-pizzas
Shakespeare’s Pizza Issues an Allergy Alert Concerning Undeclared Wheat in Its Frozen Pizzas
Summary
Company Announcement Date:  December 07, 2023
FDA Publish Date:  December 08, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat
Company Name:  Shakespeare’s Pizza
Brand Name:  Shakespeare’s
Product Description:  Frozen pizza