CA Company Recalls Tuna After Case of Scombroid Poisoning

Relish Foods, Inc of El Segundo, California voluntarily initiated the recall of Frozen Pacific Fusion Brand 10 oz Tuna Steaks. The recall was the result of a consumer complaint where after sampling by FDA revealed that the product has potential to contain elevated levels of histamines which can produce an allergic [like] reaction called scombroid fish poisoning.

Symptoms of scombroid poisoning including a tingling or burning sensation in the mouth, facial swelling, rash, hives and itchy skin, nausea, vomiting or diarrhea, can appear within minutes to several hours after eating the affected fish.

Scombrotoxin Poisoning and Decomposition (FDA) Scombrotoxin Poisoning and Decomposition | FDA and Fish and Fishery Products Hazards and Controls Guidance (fda.gov)

• "Fish most commonly involved are members of the Scombridae family (tunas and mackerels), and a few non-scombroid relatives (bluefish, dolphin or mahi-mahi, and amberjacks). can become problematic for Scombroid poisoning when the product is temperature abused."
• "The suspect toxin is an elevated level of histamine generated by bacterial degradation of substances in the muscle protein. This natural spoilage process is thought to release additional by-products which potentiate the toxic effect. The potential toxins are not destroyed by freezing, cooking, smoking, curing or canning."
• "These species should always receive special care in handling, washing, and proper icing, refrigeration or immediate freezing to prevent bacterial growth and spoilage. Studies have demonstrated toxic histamine levels can be generated within less than 6 to 12 hours exposure without ice or refrigeration." 
• This protein degradation can occur anywhere along the supply chain where there is the opportunity for temperature abuse - the boat,  processing and storage, retail and foodservice, and the home.
• "Certain bacteria produce the enzyme histidine decarboxylase during growth. This enzyme reacts with histidine, a naturally occurring amino acid that is present in larger quantities in some fish than in others. The result is the formation of scombrotoxin (histamine)."
• "Histamine-forming bacteria are capable of growing and producing histamine over a wide temperature range. Growth of histamine is more rapid, however, at high-abuse temperatures (e.g., 70°F (21.1°C) or higher) than at moderate-abuse temperatures (e.g., 45°F (7.2°C)). Growth is particularly rapid at temperatures near 90°F (32.2°C). Histamine is more commonly the result of high temperature spoilage than of long-term, relatively low-temperature spoilage, which is commonly associated with organoleptically detectable decomposition"
• "Once the enzyme histidine decarboxylase is present in the fish, it can continue to produce histamine in the fish even if the bacteria are not active. The enzyme can be active at or near refrigeration temperatures. The enzyme remains stable while in the frozen state and may be reactivated very rapidly after thawing." 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/relish-foods-inc-recalls-frozen-tuna-steaks-because-possible-health-risk
Relish Foods, Inc Recalls Frozen Tuna Steaks Because of Possible Health Risk
Summary
Company Announcement Date:  December 28, 2021
FDA Publish Date:  December 29, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Elevated levels of histamine
Company Name:  Relish Foods, Inc.
Brand Name:  Frozen Pacific Fusion Brand
Product Description:  Tuna steaks

MA Company Recalls Brownies for Pecan Allergens After Product Packed in Wrong Containers

Dianne's Fine Desserts of Newburyport, MA  is recalling 1,480 trays of Sienna® Chocolate Decadent Brownies due to a mis-pack, resulting in an undeclared tree nut (pecan).Trays of GFS Item #541850 Sienna® Chocolate Turtle Brownies, which contains pecans, may be labeled as GFS Item #226240 GFS Sienna® Chocolate Decadent Brownies, which do not contain pecans, thus resulting in an undeclared allergen.  The recall was initiated after a customer complaint with a product containing pecans was distributed in packaging that did not reveal the presence of pecans. Subsequent investigation indicates the problem was caused by a temporary breakdown in the labeling process.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/diannes-fine-desserts-issues-allergy-alert-undeclared-pecan-allergen-siennar-chocolate-decadent
Dianne's Fine Desserts Issues Allergy Alert on Undeclared Pecan Allergen in Sienna® Chocolate Decadent Brownie
Summary
Company Announcement Date:  December 28, 2021
FDA Publish Date:  December 28, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Tree Nut (Pecan)
Company Name:  Dianne's Fine Desserts
Brand Name:  Sienna
Product Description:  Chocolate Decadent Brownies

NY Company Recalls Vegetarian Pasta After Packaging Error

SEVIROLI FOODSA INC., of Garden City, NY is recalling Aplenty Rotini with Plant Based Bolognese Meal Kit due to an undeclared allergen – milk in the product.  The issue was discovered on December 22, 2021. The recall was initiated after discovering that Seviroli Foods products containing milk were inadvertently packaged in Aplenty-Rotini with Plant Based Bolognese Meal Kit packaging, which does not include milk in the ingredient statement. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/seviroli-foods-inc-garden-city-recalling-aplenty-rotini-plant-based-bolognese-meal-kit-due
Seviroli Foods Inc., of Garden City is Recalling Aplenty Rotini with Plant Based Bolognese Meal Kit Due to an Undeclared Allergen – Milk in the Product
Summary
Company Announcement Date:  December 26, 2021
FDA Publish Date:  December 27, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Milk
Company Name:  SEVIROLI FOODS, INC.
Brand Name:  Aplenty
Product Description:  Rotini with Plant based Bolognese Meal Kit

MN Firm Recalls Raw Pet Food Salmonella After Complaint

Woody’s Pet Food Deli of Minneapolis, MN is recalling Raw Cornish Hen pet food “With Supplements” sticker due to a Salmonella health risk.  The recall is a result of FDA sampling due to a consumer complaint on another product, which testing revealed a sample of this product contains Salmonella.  The company continues their investigation as to the source of the problem and will resume production when the problem is resolved. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/woodys-pet-food-deli-recalls-raw-cornish-hen-pet-food-salmonella-health-risk
Woody’s Pet Food Deli Recalls Raw Cornish Hen Pet Food for Salmonella Health Risk
Summary
Company Announcement Date:  December 23, 2021
FDA Publish Date:  December 23, 2021
Product Type:  Animal & Veterinary  Food & Beverages  Pet Food
Reason for Announcement:  Potential Salmonella
Company Name:  Woody’s Pet Food Deli
Brand Name:  Woody's Pet Food Deli
Product Description:  Raw Cornish Hen pet food “With Supplements”

Dough Sheet Products Fail to State Wheat on the Label Resulting In Allergen Related Recall

Local Fixe LLC of Roseburg, Oregon is recalling Classic Lasagna Sheets, Soup Noodles, Dinner Rolls, Pie Dough, Squid Ink - Fettucine, and Fresh Flour Tortillas because it may contain undeclared wheat.
The recall was initiated after it was discovered that products containing undeclared wheat or gluten were distributed in packaging that did not reveal the presence of wheat or gluten. 

The ingredient statement for the Classic Lasagna Sheets states:

Ingredients: Flour, Semolina, Egg, Water

The other labels are similar in that none of them state Wheat.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/local-fixe-llc-issues-allergy-alert-undeclared-wheat-classic-lasagna-sheets-soup-noodles-dinner
Local Fixe LLC Issues Allergy Alert on Undeclared Wheat in Classic Lasagna Sheets, Soup Noodles, Dinner Rolls, Pie Dough, Squid Ink – Fettucine, and Fresh Flour Tortillas
Summary
Company Announcement Date:  December 22, 2021
FDA Publish Date:  December 22, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Wheat
Company Name:  Local Fixe LLC
Brand Name:  Local Fixe LLC

Company Recalls Drink Mix After It Discovers Too Late that All Worcestershire Sauce is Not the Same

Joy’s International Foods of Melbourne, Florida is recalling the Joy’s Gourmet Bloody Mary Mix with best by date 08/18/2023, because it contains undeclared Soy & Fish.  The recall was initiated after FDA discovered that product containing Soy & Fish and was distributed in packaging that did not reveal the presence of the allergens. Subsequent investigation indicates the problem was caused by receiving a substitute to the Worcestershire sauce previously used due to supply chain failure.

Some brands of Worcestershire Sauce are made using soy sauce and anchovies, while some brands are not.  In this case, someone purchased a different brand than what was used to develop the label.  When doing the hazard analysis, these allergens must be identified regardless, and if a brand is normally used without these allergens, then not only should the Hazard Analysis still identify these hazards requiring control  (such as incoming product label review), but the product specification must also clearly state the brands to be purchased must not contain these allergens.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/joys-international-foods-issues-allergy-alert-undeclared-soy-fish-joys-gourmet-bloody-mary-mix
Joy’s International Foods Issues Allergy Alert on Undeclared Soy & Fish in Joy’s Gourmet Bloody Mary Mix
Summary
Company Announcement Date:  December 22, 2021
FDA Publish Date:  December 22, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Contains Undeclared Soy & Fish.
Company Name:  Joy’s International Foods
Brand Name:  Joy’s Gourmet
Product Description:  Bloody Mary Mix

Dole Fresh Vegetables Recalls a Multitude of Products After Linked to Listeria Outbreak

The FDA and CDC are investigating a multistate outbreak of Listeria monocytogenes infections potentially linked to Dole packaged leafy greens. According to the CDC, as of December 22, 2021, 16 people infected with the outbreak strain of Listeria monocytogenes have been reported from 13 states.  Illnesses started on dates ranging from August 16, 2014 to October 17, 2021 (one case occurred in 2014 and the remaining cases occurred between 2018 and 2021).

Case Counts
Total Illnesses: 16
Hospitalizations: 12
Deaths: 2
Last Illness Onset: October 17, 2021
States with Cases: IA, ID, MD, MI, MN, NC, NV, OH, OR, PA, TX, UT, WI
Product Distribution*: AL, AZ, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MS, NC, ND, NY, OH, PA, SC, TN, TX, VA, WI

• CDC investigated this outbreak in 2019 and 2020 and reopened the investigation in November 2021 when four new illnesses were reported since the end of August.  
• In October 2021, as a part of routine retail sampling, the Georgia Department of Agriculture collected a product sample of prepackaged salad mix from a grocery store for testing. The sample tested positive for Listeria monocytogenes. In response to the sample results, Dole initiated a recall of packaged garden salads in October 2021. These products are now past their “Best if Used By” dates. 
• The positive sample was later sent for whole genome sequencing (WGS) analysis; and in December 2021, WGS analysis was completed. The results show that the Listeria monocytogenes in the product sample was a match to the outbreak strain. FDA is conducting an inspection at the facility that produced the product that tested positive for Listeria monocytogenes.
• The Michigan Department of Agriculture and Rural Development also recently initiated retail sampling of Dole products in their state as part of this investigation. One product containing lettuce from the Dole facility in Yuma, AZ, tested positive for Listeria monocytogenes. WGS analysis showed that the Listeria monocytogenes in the product sample is also a match to the outbreak strain.
• In response to the sample analyses and the ongoing outbreak investigation, Dole has agreed to voluntarily suspend operations at both the Bessemer City, NC, facility and Yuma, AZ, facility and has voluntarily recalled all products and brands from those facilities. Those products have production lot codes beginning with either the letter “N” or “Y” in the upper right-hand corner of the package and Best if Used By dates from November 30, 2021 to January 8, 2022.

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-listeria-monocytogenes-dole-packaged-salad-december-2021
Outbreak Investigation of Listeria monocytogenes: Dole Packaged Salad (December 2021)
Do not eat, sell, or serve recalled Dole packaged salads; FDA investigation ongoing

FDA Warning Letter - Small Family-run Tortilla Company Still Does Not Have Food Safety Plan

What happens when the FDA gives you a chance to write your food safety plan and you don't do it - they issue you a Warning Letter.  Sarita's Tortilla Factory, Inc, a small company located in Eagle Pass TX had an inspection in July of 2019, during which, the company stated that they would write a Food Safety Plan.   During reinspection in July of 2021, there was no plan.   So FDA issued a Warning Letter to the company for not having a Food Safety Plan as required by regulation.

In addition, a number of GMPs were listed on the Warning Letter.  These include:

• Water was dripping from a ceiling with peeling paint onto a pallet of (b)(4)-(b)(4) bags of flour.
• Filth was present on metal air vents and fans located directly above RTE soft flour and corn tortillas.
• There were no procedures to ensure cleaning compounds and sanitizing agents are safe and adequate
• A live frog was inside the raw ingredients room, under a pallet of wheat flour. The frog was observed to enter the facility through a gap in the loading bay door.
• An unscreened door was open at the north side of the facility during the production of soft flour and corn tortillas.
• There were gaps along two screened doors located in your facility’s loading areas on the northeast side and west side of the building.
• An employee inserted an approximately 12-inch piece of splinted wood into corn tortilla dough 
• Used non-food-grade grease on tortilla production equipment.

From the company's Facebook page, it seems to be a very nice, small family run company that has been in business for at least four years.  But as we have seen with other small companies that move beyond retail sales into further distribution, they now fall under the Federal regulations. While GMPs must be adheere to for all food operations, the step up to writing and implementing a Food Safety Plan can be a challenge, but one that can be overcome, and needs to be overcome.  Or in this case, the company may file as a Qualified Facility, depending on the amount of sales. 

Sarita's Tortilla Factory, Inc - 617384 - 11/22/2021 | FDA
Sarita's Tortilla Factory, Inc

Fresh Express Recalls a Multitude of Salad Items After Testing Finds Listeria that Matches Outbreak Strain

Fresh Express is recalling certain varieties of its branded and private label salad products produced at the company’s Streamwood, Illinois facility because the product has the potential to be contaminated with Listeria monocytogenes. The recall was necessitated when the Michigan Department of Agriculture received a positive result for Listeria monocytogenes in a random sample test of a single package of Fresh Express 9 oz. Sweet Hearts salad mix with Use-By Date of December 8, 2021, manufactured at the Fresh Express Streamwood facility.

The FDA and CDC are investigating a multistate outbreak of Listeria monocytogenes infections. As of December 21, 2021, 10 people infected with the outbreak strain of Listeria monocytogenes have been reported from eight states. Illnesses started on dates ranging from July 26, 2016 to October 19, 2021.

The sample of Fresh Express Sweet Hearts salad mix with a Use-By-Date of December 8, 2021 collected and tested by Michigan Department of Agriculture and Rural Development (MDARD) tested positive for Listeria monocytogenes and subsequent whole genome sequencing (WGS) analysis determined that the Listeria monocytogenes present in the samples matches the strain that has caused illnesses in this outbreak.

Case Counts

Total Illnesses: 10

Hospitalizations: 10

Deaths: 1

Last Illness Onset: October 19, 2021

States with Cases: IL, MA, MI, NJ, NY, OH, PA, VA

Recalled Brands include - Bowl and Basket, Fresh Express, Giant Eagle, Little Salad Bar, Market District, Marketside, O Organics, Signature Farms, Simply Nature, Weis Fresh from the Field, and Wellsley Farms. Recalled salad items were distributed through retailers in the Northeast and Midwest regions of the United States, as well as distributors and retailers in Canada. U.S. distribution includes the states of CT, IA, IL, IN ,KY, MA, MD, ME, MI, MN, MO, ND, NH, NJ, NY, OH, PA, RI, WI. Canadian distribution includes the provinces of Ontario and Manitoba.

Look for codes on front of bag -  Z324 through Z350




https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresh-express-announces-recall-fresh-salad-products-due-potential-health-risk
Fresh Express Announces Recall of Fresh Salad Products Due to Potential Health Risk
Summary
Company Announcement Date:  December 20, 2021
FDA Publish Date:  December 21, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Possible Listeria monocytogenes.
Company Name:  Fresh Express
Brand Name:  Fresh Express, Bowl and Basket, Giant Eagle, Marketside and Others
Product Description:  Multiple Fresh Salad Products