Wednesday, March 23, 2022

Company Recalls Airborne Gummies Due to Container Caps Going Airborne

Reckitt is recalling over 3 million bottles of their famous Airborne Gummies after receiving 70 reports of the seals and caps popping off when opening.  This has resulting in 18 minor injuries.  It seems the jars are over pressurized resulting in the seals and caps popping off the bottles.

Airborne is formulated to support the immune system, but the immune system is not much help against a flying cap (unless to fight infection from the infliction caused by the flying cap).

https://www.cpsc.gov/Recalls/2022/Reckitt-Recalls-More-than-Three-Million-Bottles-of-Airborne-Gummies-Due-to-Injury-Hazard
Reckitt Recalls More than Three Million Bottles of Airborne Gummies Due to Injury Hazard

Name of Product: Airborne Gummies (63 and 75 count bottles)  
Hazard: When opened for the first time, pressure build up in the bottle can cause the cap and underlying seal to pop off with force, posing an injury hazard.

FDA Warning Letter for Raw Dog Food Operation For Not Controlling Pathogenic Bacteria

FDA issued a Warning Letter to a California based manufacturer of 'raw dog food'.  In a nutshell, the facility was not really controlling pathogens such as Salmonella or Listeria...in the raw product or from the environment.  Their supposed control for the raw product was intermittently spraying a chemical on the frozen meat at the chipper.  There was improper validation support for efficacy of this procedure (what they were doing was different than the study parameters).  In the environment, Salmonella and Listeria were recovered including from product contact surfaces. 

You can read more about OC Raw Dog from their website. https://ocrawdog.com/testimonials/faqs/

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/oc-raw-dog-llc-615550-02232022
WARNING LETTER
OC Raw Dog LLC

MARCS-CMS 615550 — FEBRUARY 23, 2022

FDA Releases 483 Reports for Infant Formula Manufacturer of Recalled Dried Powder Formula

FDA released its recent inspectional report (FDA 483 Inspectional Observations) dated 1/31-22 to 3/18-22 for Abbott Laboratories' Sturgis Michigan facility. This facity recently recalled baby formula after being linked to 4 infant deaths due to Cronobacter sakazakii. C. sakazakii is a bacterial hazard in baby formula because it can lead to severe infection in death in infants, especially those born prematurely.

From the CDC: "Cronobacter germs can cause a dangerous blood infection (sepsis) or make the linings surrounding the brain and spinal cord swell (meningitis). Infants 2 months of age and younger are most likely to develop meningitis if they get sick from Cronobacter. Other infants more likely to get sick are those born prematurely and those less able to fight germs and sickness because of illness or medical treatment, such as infants receiving chemotherapy for cancer."

A few items from the 483 Report
  • FDA found C. sakazakii in the medium and high cares areas on Zone 2 and 3 samples, (with Zone 2 being surfaces adjacent to product contact surfaces and Zone 3 being further away such as floor samples).
  • The firm also had positive environmental samples and finished product over a 2.5 year period.
  • During inspection, there was a water leak issue in the dryer area, which is supposed to be a dry area. Water issues had been a long identified issue in the facility
  • Product contact surfaces were not adequately protected from contamination. (Obs 2)
  • Inadequate follow up on consumer complaints (Obs 3)
  • Poor adherence to Personal Hygiene program for wearing protective gear (Obs 4) including people failing to sanitize designated work (captive) shoes as they move from area to area.
If you are unfamiliar with a 483 report and the type of issues noted on a report, you may want to check this out.

One thing that stands out is the lack of root cause analysis for issues experienced over time coupled with lax protocols.


Monday, March 21, 2022

More Food Importers Failing to Meet Regulatory Requirements for FSVP- March 22 Version

Over the past two weeks, FDA has issued Warning Letters to a half dozen food importers for not have the required FSVP in place for the items those companies were importing.

Euphrates Foods, LLC dba Labeeb Alani Inc. of Elk Grove Village, IL.did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a) for their imported food including Roasted white pumpkin seeds and nuts in-shell imported from (b)(4)  and Pistachio toffee imported from (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/euphrates-foods-llc-dba-labeeb-alani-inc-618723-12232021

FELLA GROUP LLC, of  Irvine, CA did not develop an FSVP for each of the following foods:  Mayocoba Beans imported from (b)(4)  Chick Peas (Garbanzo Beans) imported from (b)(4), Rustic Salad Dressing imported from (b)(4) and other imported foods
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fella-group-llc-625512-02252022

Keeler Family Farms of  Deming, NM.did not develop an FSVP for any foods imported, including whole, fresh onions imported from foreign suppliers, (b)(4), located in Chihuahua, Mexico.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/keeler-family-farms-624666-03022022

Global LC Inc DBA Rice Chicken, of San Diego, CA 9212  did not develop an FSVP for any of the  imported food, including  Batter mix imported from (b)(4) located in (b)(4) and b. Yang Neum sauce (Mild taste marinade) and roasted seasoning imported from (b)(4) located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/global-lc-inc-dba-rice-chicken-623004-02042022

SERGIO CARRANZA DBA MR CHESCOS, of Houston, Texas. did not develop an FSVP for any of the imported foods, including the following:
• Cola flavored carbonated soft drinks imported from foreign supplier (b)(4)
• Grape flavored carbonated soft drinks imported from foreign supplier (b)(4)
• Banana flavored carbonated soft drinks imported from foreign supplier (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sergio-carranza-dba-mr-chescos-619398-02032022

All Good Foods, Inc. of Industry, CA 91745-1814. did not develop, maintain, and follow an FSVP for any of the imported foods, including each the following food products:
Frozen Tiny Red Chili imported from your foreign supplier, (b)(4) in (b)(4)
Frozen Chopped Lemon Grass imported from your foreign supplier, (b)(4) in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/all-good-foods-inc-624303-02072022

NY Firm Recalls All Fresh Cut Fruit and Vegetable Products and RTE Dips After Sampling Program Discovers Listeria On Equipment Surfaces

Fruit Fresh Up, Inc. is voluntarily recalling from the market all fresh cut fruit and vegetable products and ready to eat dips, as listed below, processed at its Depew, NY production facilities, due to a possible health risk from Listeria monocytogenes.  Products subject to the voluntary recall of fresh cut fruits and vegetables are packaged in clear plastic containers with a tamper evident seal and identified with a “Best if Used By” date between March 5, 2022, and March 23, 2022. Ready-to-eat dips are provided in 7oz clear plastic clamshell containers with a Best if Used By date of March 15, 2022 to March 31, 2022.  This voluntary recall notification is being issued after results from the environmental program found surfaces where products are packaged into containers to contain Listeria monocytogenes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fruit-fresh-inc-recalls-products-due-possible-health-risk
Fruit Fresh Up, Inc Recalls Products due to Possible Health Risk
Summary
Company Announcement Date:  March 20, 2022
FDA Publish Date:  March 20, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Listeria monocytogenes
Company Name:  Fruit Fresh Up, Inc.
Brand Name:  
  • Wegmans
  • Fresh Harvest
  • Lexington Co-op
  • Tops
Product Description: Fresh cut fruit and vegetable products

CA Firm Recalls French Vanilla Yogurt After Mislabeling Issue Results in Undeclared Egg Allergen

St. Benoit Creamery of Sonoma, CA is recalling French Vanilla Yogurt, lot code # 2054, best by date 8/22/2022, because it may contain undeclared EGG allergen.  The recall was initiated after it was discovered that the Organic Desserts Pot De Crème Vanilla was mis-labeled as French Vanilla Yogurt and it did not reveal the presence of the EGG allergen.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/st-benoit-creamery-issues-allergy-alert-undeclared-egg-french-vanilla-yogurt
St. Benoit Creamery Issues Allergy Alert on Undeclared Egg in French Vanilla Yogurt
Summary
Company Announcement Date:  March 19, 2022
FDA Publish Date:  March 19, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared egg
Company Name:  St. Benoit Creamery
Brand Name:  St. Benoit Creamery
Product Description:  French Vanilla Yogurt

More Enoki Mushrooms Recalled Due to Listeria Risk

(Updated 3-22-22) Four companies are recalling enoki mushrooms due to Listeria.

Jan Fruits Inc. of VERNON, CA is recalling all its cases of its 200g/7.05oz packages of ENOKI MUSHROOM (Product of Taiwan) because it has the potential to be contaminated with Listeria monocytogenes. The recalled Enoki Mushroom product was distributed in CA to produce distributors or wholesalers for further distribution to retail stores.

T Fresh Company of City of Industry, CA is recalling its 5.25oz (150g) enoki mushrooms, Lot #6021053 grown in China & 7.5oz (200g) Lot # 6021052 grown in China, because it has the potential to be contaminated with listeria monocytogenes Lot #6021053 was distributed from California and Texas to retail stores through produce distributors.

Farm Fresh Produce LLC of Vernon, CA, is recalling all of the 14.11 ounce packages of "TWA AGRICULTURE MIXED MUSHROOMS" [which contain enoki mushrooms)

Top Quality Produce of Irwindale CA is recalling all cases of 200g/7.05oz package of Enoki Mushroom, product of Taiwan sold during 3/1/22-3/16/22 due to the Listeria contamination of Enoki mushrooms was discovered.

In all cases, the potential for contamination was discovered after a retail sample collected and analyzed by California Department of Public Health (CDPH) and revealed the presence of Listeria monocytogenes in 7.05 oz. package of Enoki mushroom.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/jan-fruits-inc-recalls-enoki-mushrooms-because-possible-health-risk-0
Jan Fruits Inc. Recalls Enoki Mushrooms Because of Possible Health Risk
Summary
Company Announcement Date: March 18, 2022
FDA Publish Date: March 18, 2022
Product Type: Food & Beverages
Reason for Announcement: Listeria monocytogenes
Company Name: Jan Fruits, Inc.
Brand Name: Taiwan Best Quality
Product Description: Enoki Mushrooms

Gluten-Free Coconut Flour Tortillas Recalled After Wheat-containing Product in Packages

The Salsa Texan of Flower Mound, Texas is voluntarily recalling its regular and burrito sized packages of Coconut Flour Tortillas because they may contain undeclared wheat. The voluntary recall was initiated after it was discovered that the wheat containing product was distributed in packaging that did not reveal the presence of wheat. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/salsa-texan-issues-allergy-alert-undeclared-wheat-contamination-gluten-free-coconut-flour-tortillas
The Salsa Texan Issues Allergy Alert on Undeclared Wheat Contamination in “Gluten Free Coconut Flour Tortillas”
Summary
Company Announcement Date:  March 18, 2022
FDA Publish Date:  March 18, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat
Company Name:   The Salsa Texan
Brand Name:  The Salsa Texan
Product Description:   Coconut Flour Tortillas

Pancake Mix Recalled After Fragments of Cable From Processing Line Found in Product

Continental Mills has issued a recall of Kroger Buttermilk Pancake & Waffle Mix, AND Walmart Great Value Buttermilk Pancake & Waffle Mix, UPC 078742370828, Lot code KX2063, Best By Date of 09/01/2023  due to a potential foreign material contamination. Fragments from a cable used to clear the processing line were discovered in a limited amount of product.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/continental-mills-recalls-kroger-buttermilk-pancake-waffle-mix-due-possible-foreign-material
Continental Mills Recalls Kroger Buttermilk Pancake & Waffle Mix Due to Possible Foreign Material Contamination
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/continental-mills-recalls-kroger-Buttermilk-pancake-waffle-mix-due-possible-foreign-material
Summary
Company Announcement Date:  March 18, 2022
FDA Publish Date:  March 18, 2022
Product Type:   Food & Beverages
Reason for Announcement:  Potential foreign material contamination
Company Name:  Continental Mills
Brand Name:  Kroger
Product Description:  Buttermilk Pancake & Waffle Mix

Hash Browns Recalled for Undeclared Wheat After Supplier Labeling Issue

Cavendish Farms Corporation of Dieppe, New Brunswick, Canada, is recalling 441 cases of its 42.3 oz packages of Original Hash Brown Patties because they may contain undeclared wheat.   No confirmed illnesses have been reported to date in connection with this problem.  The recall was initiated after it was discovered the product contained wheat and was distributed in packaging that did not reveal the presence of wheat. Cavendish Farms was notified by a supplier that an ingredient it provided was mislabeled and did not identify the presence of wheat.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cavendish-farms-issues-allergy-alert-undeclared-wheat-original-hash-brown-patties
Cavendish Farms Issues Allergy Alert on Undeclared Wheat in Original Hash Brown Patties
Summary
Company Announcement Date:  March 17, 2022
FDA Publish Date:  March 17, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat
Company Name:  Cavendish Farms Corporation
Brand Name:  Cavendish Farms
Product Description:   Hash Brown Patties

Tuesday, March 15, 2022

Lancaster Farmer Fights the Courts on Food Safety Rules

There is an ongoing court action involving Lancaster, PA farmer Amos Miller as he tries to write his own rules for food safety.  Our good friend George Lapsley took the Justice Department's assignment for verifying that the Miller Organic Farm would adhere to the court order, but  Miller's refusal to work with George has landed Miller back in court.  Miller claims sovereign citizen rights, that is, that he has the right to set his own rules....but the court is not having any of it.   


https://lancasteronline.com/news/local/lancaster-farmer-agrees-again-to-follow-court-order-after-refusing-to-allow-food-safety-expert/article_dc563262-9feb-11ec-9847-eb35032cf6e9.html
Lancaster farmer agrees, again, to follow court order after refusing to allow food safety expert to inspect farm
DAN NEPHIN | Staff Writer Mar 10, 2022

A month ago, a federal judge appointed an expert to work with Upper Leacock farmer Amos Miller to make sure he complied with food safety laws and court orders — something he’s shown an unwillingness to do for years.

Monday, March 14, 2022

Europe - Bottle of Champagne Contaminated With the Drug Ecstasy Kills One and Sickens 8

One man died and 8 others hospitalized in Germany and the The Netherlands after drinking champagne spike with a high level of the drug Ecstasy.  It is unknown how the bottles became laced with the drug.  The news report stated that the bottles of Moët & Chandon Ice Impérial were purchased on the internet.
"Toxicology reports found the champagne contained 1,000 times the normal dose of ecstasy, so much that the beverage had turned purple, according to the Daily Beast. Police do not believe the drinkers were aware of the drug or had added it themselves".

Clearly a case of intentional contamination.  Perhaps the bottles were spiked as a means to ship the drug and then were inadvertently sold?


https://www.insider.com/luxury-moet-champagne-spiked-with-ecstasy-kills-man-12-poisoned-2022-3
Man dies and 12 people are taken ill after drinking a $480 bottle of champagne spiked with ecstasy
Bethany Dawson Mar 6, 2022, 11:46 AM

A man has died and 12 became ill in Germany and The Netherlands after drinking a bottle of luxury champagne laced with ecstasy.

Friday, March 11, 2022

RTE Chicken Salad Recalled After Supplier of Salad Dressing Discovers Foreign Material Issue

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for a ready-to-eat (RTE) chicken salad product containing a Food and Drug Administration (FDA) regulated salad dressing that has been recalled by the producer due to concerns that the salad dressing may contain hard plastic.  The problem was discovered when an FSIS inspected establishment received notification from their salad dressing supplier that the salad dressing, which is regulated by FDA, may contain hard plastic.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-chicken-salad-products-containing-fda-regulated
FSIS Issues Public Health Alert for Chicken Salad Products Containing FDA-Regulated Dressing that has been Recalled due to Foreign Material Contamination
R & G FINE FOODS, INC.

FSIS Announcement

WASHINGTON, March 10, 2022 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for a ready-to-eat (RTE) chicken salad product containing a Food and Drug Administration (FDA) regulated salad dressing that has been recalled by the producer due to concerns that the salad dressing may contain hard plastic. FSIS is issuing this public health alert to ensure that consumers are aware that these products should not be consumed.

Dark Chocolate Espresso Beans Recalled for Containing Chocolate Covered Peanuts Instead

Albanese Confectionery Group, Inc. of Merrillville, Indiana is voluntarily recalling Albanese® Dark Chocolate Espresso Beans, 9 oz tub, because it may contain an undeclared peanut allergen. The recall was initiated after it was discovered that Dark Chocolate Panned Peanuts were inadvertently packaged in the Dark Chocolate Espresso Bean tubs.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/albanese-confectionery-group-inc-recalls-dark-chocolate-espresso-bean-9-oz-tub-because-undeclared
Albanese Confectionery Group, Inc. Recalls Dark Chocolate Espresso Bean 9 Oz. Tub Because of Undeclared Peanut Allergen
Summary
Company Announcement Date:  March 10, 2022
FDA Publish Date:  March 10, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared peanuts
Company Name:  Albanese Confectionary Group, Inc.
Brand Name:  Albanese
Product Description:  Dark Chocolate Espresso Beans

Spinach and Artichoke Dip Recalled After Incorrect Packaging Results in Undeclared Allergen

Fairmont Foods, Inc. of Fairmont, MN is recalling corrugated boxes of Schwan’s Brand “Spinach and Artichoke Dip” with date code P82013 xxxx due to undeclared soy and wheat.  The recall was initiated after it was discovered that the incorrect packaging had been used.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fairmont-foods-inc-issues-recall-spinach-and-artichoke-dip-product-due-misbranding-and-undeclared
Fairmont Foods, Inc. Issues Recall of Spinach and Artichoke Dip Product Due to Misbranding and Undeclared Soy and Wheat Allergens
Summary
Company Announcement Date:  March 10, 2022
FDA Publish Date:   March 10, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared soy and wheat
Company Name:  Fairmont Foods, Inc.
Brand Name:  Schwan’s
Product Description:  Spinach and Artichoke Dip

Frozen Bagels Recalled After Mispackaging Results in Undeclared Egg Allergen

Damascus Bakery OPCO LLC is voluntarily recalling one production lot (#12031) of Bantam Classic Bagels due to an incorrect item being placed in the carton with an undeclared egg allergen.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/damascus-bakery-recalls-one-lot-bantam-classic-bagels
Damascus Bakery Recalls One Lot of Bantam Classic Bagels
Summary
Company Announcement Date:  March 02, 2022
FDA Publish Date:  March 09, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared eggs
Company Name:  Damascus Bakery OPCO LLC
Brand Name:  Bantam Classic
Product Description:  Stuffed Bagels with Cream Cheese

OH Firm Recalls 'Einkorn' Products for Not Declaring Wheat Because Einkorn is Wheat

Stutzman Farms of Millersburg, Ohio is voluntarily recalling all products containing einkorn as the product labels do not declare wheat, a known allergen, on the product label. Stutzman Farms became aware of the misbranding issue after it was brought to our attention by the Ohio Department of Agriculture.

From the Einkorn.com website "Einkorn is the oldest wheat known to scientists, and is considered man’s first wheat. The term einkorn is derived from the German language and interpreted to mean “single grain”. Einkorn wheat is known in taxonomy as either Triticum boeoticum (wild wheat), or Triticum monococcum (domesticated species). Domesticated and wild forms of wheat may be considered either as separate species, or as Triticum monococcum’s subspecies."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/stutzman-farms-issues-voluntary-recall-its-einkorn-products-undeclared-wheat-allergen
Stutzman Farms Issues a Voluntary Recall of its Einkorn Products for an Undeclared Wheat Allergen
Summary
Company Announcement Date:  March 08, 2022
FDA Publish Date:  March 09, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat
Company Name:  Stutzman Farms
Brand Name:  Stutzman Farms
Product Description:  Products containing einkorn: berries, flour, pretzel, more.

Abbott Expanded Recall of One Lot of Baby Formula

Abbott is voluntarily recalling one lot of Similac PM 60/40 (Lot # 27032K80 (can) / Lot # 27032K800 (case)) manufactured in Sturgis, Michigan. This is in addition to lots of Similac®, Alimentum® and EleCare® powder formula that were voluntarily recalled on Feb. 17. The action comes after learning of the death of an infant who tested positive for Cronobacter sakazakii and who we were informed had consumed Similac PM 60/40 from this lot.  Importantly, no distributed product has tested positive for the presence of Cronobacter sakazakii. Additionally, recently tested retained product samples of Similac PM 60/40 Lot # 27032K80 (can) / Lot #27032K800 (case) were negative for Cronobacter.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-voluntarily-expands-recall-powder-formulas-manufactured-one-plant
Abbott Voluntarily Expands Recall of Powder Formulas Manufactured at One Plant
Summary
Company Announcement Date:  February 28, 2022
FDA Publish Date:  March 07, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Consumer complaints regarding Cronobacter sakazakii, Salmonella Newport
Company Name: Abbott
Brand Name:  Similac, Alimentum, and EleCare
Product Description:  Powder Infant Formula

Monday, March 7, 2022

CA Establishment Recalls Jerky Products After USDA Sampling Finds Listeria Positive Sample

Boyd Specialties, LLC, a Colton, Calif. establishment, is recalling approximately 1,634 pounds of ready-to-eat (RTE) jerky products that may be adulterated with Listeria monocytogenes.  The problem was discovered by FSIS during follow-up procedures after a routine FSIS product sample confirmed positive for Listeria monocytogenes.

The product was packed under a variety of label brands and was shipped to retail locations in Alabama, California, Connecticut, Michigan, New Jersey, North Carolina, Pennsylvania, and Texas

Currently, the recall is limited to one day of production (Feb 23, 2022), but with recalls of this nature, it would not be surprising to see this recall expanded.

https://www.fsis.usda.gov/recalls-alerts/boyd-specialties-llc-recalls-jerky-products-due-possible-listeria-contamination
Boyd Specialties, LLC Recalls Jerky Products Due to Possible Listeria Contamination
BOYD SPECIALTIES LLC


FSIS Announcement

WASHINGTON, March 4, 2022 – Boyd Specialties, LLC, a Colton, Calif. establishment, is recalling approximately 1,634 pounds of ready-to-eat (RTE) jerky products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

FDA Releases Final Guidance for Conducting A Voluntary Recall

FDA released its finalized guidance for conducting a voluntary recall.  The document, "Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C", was issued as a draft in 2019.   It discusses the various elements of a recall including having a recall plan, conducting training, maintaining records, and interacting with the FDA.  There were some minor changes from the draft including adding terminology, including the term "market withdrawals".

It would be worthwhile downloading this document and reviewing it against your current recall plan.

FDA Guidance
Guidance--Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C (fda.gov)
Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff

INTRODUCTION

The purpose of this guidance is to clarify FDA’s recommendations for industry and Agency staff 
regarding timely initiation of voluntary recalls under 21 CFR part 7, subpart C – Recalls (Including Product Corrections) – Guidance on Policy, Procedures, and Industry Responsibilities. The guidance discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures; to ensure timely identification of, and response to, product problems that might lead  to a recall; and to promptly issue recall communications and press releases or other public notices. It also discusses preparations firms in the distribution chain should consider making to ensure timely responses to a recall communication. Additionally, it discusses how FDA assists firms with carrying out their recall responsibilities to protect the public health from distributed products in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other laws administered by FDA.

This guidance applies to voluntary recalls of products subject to FDA’s jurisdiction, including any food, drug, and device intended for human or animal use, any cosmetic and biological product intended for human use, any tobacco product intended for human use, and any item subject to a quarantine regulation under 21 CFR part 1240. This guidance applies to devices that are electronic products regulated as radiology devices subject to 21 CFR part 892. It does not apply to electronic products subject to 21 CFR parts 1003 and 1004. 

MO Company Recalls Beef Sticks After Recognition The Gluten Free Declaration Wrong Because Product Contains Wheat

Frickenschmidt Foods LLC, a Lockwood, Mo. establishment, is recalling approximately 5,795 pounds of ready-to-eat beef stick products due to misbranding, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains and declares wheat as an ingredient but has an incorrect statement of “gluten free” on the label. The problem was discovered when the distribution company notified the establishment that the product is labeled as “gluten free” but lists wheat in the ingredients statement.




https://www.fsis.usda.gov/recalls-alerts/frickenschmidt-foods-llc-recalls-ready-eat-beef-stick-products-due-misbranding
Frickenschmidt Foods LLC Recalls Ready-to-Eat Beef Stick Products Due to Misbranding
FRICKENSCHMIDT FOODS LLC
FSIS Announcement

WASHINGTON, Feb. 22, 2022 – Frickenschmidt Foods LLC, a Lockwood, Mo. establishment, is recalling approximately 5,795 pounds of ready-to-eat beef stick products due to misbranding, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains and declares wheat as an ingredient but has an incorrect statement of “gluten free” on the label.

Chocolate Covered Cherries Recalled After Product Inadvertently Mixed with Almond Containing Product

Torn & Glasser of Pomona, CA is recalling 231 cases (2,772 units) of Dark Chocolate Covered Cherries due to an undeclared allergen. The Dark Chocolate Covered Cherries may also contain Dark Chocolate Almonds which are Tree Nuts (Almond) allergen.  The recall was initiated after it was discovered that product containing Dark Chocolate Covered Cherries was mixed with Dark Chocolate Covered Almonds in the bag. Subsequent investigation indicates that some Dark Chocolate Covered Almonds were used for Dark Chocolate Covered Cherries by Production personnel.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/urgent-torn-glasser-recalls-sprouts-farmer-market-dark-chocolate-covered-cherries-12-oz-because
Urgent: Torn & Glasser Recalls Sprouts Farmer Market Dark Chocolate Covered Cherries 12 Oz. Because of Undeclared Almond Allergen
Summary
Company Announcement Date:  March 04, 2022
FDA Publish Date:   March 04, 2022
Product Type:  Food & Beverages  Snack Food Item  
Reason for Announcement:  Undeclared almonds
Company Name:  Torn & Glasser
Brand Name:  Sprouts Farmers Market
Product Description:  Dark Chocolate Covered Cherries

Bakery Items Recalled After Label Printer Misses The Allergen Statement

The Third Synthesis Inc DBA Chicago Sweet Connection Bakery is issuing a voluntary recall for fresh baked Coffee Cakes (Various Flavors) and fresh baked Paczkis (Various Flavors) produced between February 21st, 2022 to February 23rd, 2022 because the label does not declare Egg, Milk, and Wheat.
The recall was initiated after it was discovered that the allergen statement was not correctly printing on labels due to a computer error. The label was being cut off before the allergen statement could print. Products produced after these dates have been corrected.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/third-synthesis-inc-issues-allergy-aert-undeclared-egg-milk-and-wheat-allergen-statement
The Third Synthesis Inc Issues Allergy Alert on Undeclared Egg, Milk, and Wheat Allergen Statement
Summary
Company Announcement Date:  February 28, 2022
FDA Publish Date:  March 03, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared egg, wheat, milk allergen
Company Name:  Chicago Sweet Connection Baker
Brand Name:  Chicago Sweet Connection Bakery
Product Description:   Coffee cake and paczkis varieties

Wednesday, March 2, 2022

USDA Issues Warning for Product that Contains Unlabeled Allergen Due to Supplier Error

USDA - FSIS is issuing a public health alert for various ready-to-eat (RTE) meat products containing a FDA regulated seasoning mix that has been recalled by the producer, PS Seasoning of Iron Ridge, Wis., due to concerns that the seasoning mix may contain undeclared wheat.   The problem was discovered when the FSIS inspected establishments received notification from their seasoning supplier that the seasoning mix, which is regulated by FDA, may contain undeclared wheat. The establishments then notified FSIS of the issue. FSIS and FDA are coordinating on this issue.

This is a supplier issue with mislabeling that affects downstream producers.  This supplier should have had an Allergen Preventive Control in place to ensure proper labeling.  But as the purchaser of that product, a company should understand the need for that supplier to have such controls in place.  How would they know that there is such a need?  If a spice supplier is packing various products with different allergen groupings, they would need such controls.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-ready-eat-meat-products-containing-fda-regulated
FSIS Issues Public Health Alert for Ready-to-Eat Meat Products Containing FDA-Regulated Seasoning Mix That Has Been Recalled Due to Misbranding and an Undeclared Allergen

FDA Issues Warning Letter After Recall Due to Undeclared Allergen Due to Mislabeling Error

FDA issued a Warning Letter to Cedar’s Mediterranean Foods Inc. after a October 2021 recall where the company's Organic Mediterranean Hommus was labeled with the ingredient declaration for its Organic Everything Hommus in that the finished product label did not declare a major food allergen--tree nuts (i.e., Pine Nut).

The company provided FDA the reason for mistake - "stated that the root cause of the problem was that an employee failed to follow the label change over procedure and performed an unauthorized label change. The email also stated that you retrained all employees that perform labeling, took disciplinary action against the employee that performed the unauthorized change, and that you will develop a label reconciliation program."   In response FDA stated "it appears that you did not implement adequate allergen preventive controls."

The responsibility should not be on one employee, but a Preventive Control that incorporates monitoring and verification by additional employees.

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cedars-mediterranean-foods-inc-623473-02112022
Cedar’s Mediterranean Foods Inc.
MARCS-CMS 623473 — FEBRUARY 11, 2022

First Possible Case of COVID-19 Transmission from Deer to Human

Researchers may have identified one of the first cases of transmission of COVID-19 from white tailed deer to a person.  We have known that white tailed deer can carry the COVID-19 virus.   (Plus they are notorious non-maskers.)   A specific strain of COVID that was common among the deer crowd popped up in a human.  And that human was said to be associating with the white tail deer.  (We do not now the extent of this association, but one could guess that the human probably entered into this 'association' unmasked.

Researchers to not want to get anyone alarmed.  No reason for having to wear a mask while hiking in the woods or forcing the deer into wearing a mask through passing mandated mask-for-deer legislation.

Live Science
https://www.livescience.com/deer-to-human-covid-19-transmission
1st possible case of deer-to-human COVID-19 transmission reported
By Rachael Rettner 3/1/22
So far, it seems to be an isolated COVID-19 case.