Poppies International, Inc. of Battleboro, NC is issuing a voluntary recall of selected products that were made during December 7-10, 2021, due to the possible presence of small metal fragments. The issue was discovered during production. No injuries or incidents have been reported in connection with the recalled items.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/poppies-international-inc-battleboro-north-carolina-issues-voluntary-recall-certain-lots-chocolate
Poppies International, Inc. Battleboro, North Carolina Issues Voluntary Recall on Certain Lots of Chocolate Enrobed and Cream Puff Products Due to Possible Presence of Metal
Summary
Company Announcement Date: December 28, 2021
FDA Publish Date: December 29, 2021
Product Type: Food & Beverages
Reason for Announcement: Possible presence of small metal fragments.
Company Name: Poppies International, Inc.
Brand Name: Delizza
Product Description: Cream Puffs
Monday, January 3, 2022
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)
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
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
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
Monday, December 27, 2021
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
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”
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 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
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
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
Thursday, December 23, 2021
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
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
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
Wednesday, December 22, 2021
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:
Sarita's Tortilla Factory, Inc - 617384 - 11/22/2021 | FDA
Sarita's Tortilla Factory, Inc
- 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
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