Friday, April 21, 2023

Various Imported Snack Items Recalled After Label Design Misses Milk Present in Spice Blend

JABSONS FOODS PVT LTD is voluntarily recalling Tandoori Roasted Chana (Chick Peas), Tandoori Roasted Peanut, Tandoori KajuCashew Nuts , Tandoori Peanut Spread, Thai sweet Chilli Roasted Peanut because they contains undeclared Milk. Product was sold at retail stores in New Jersey, New York, Florida, Texas, Virginia, Los Angeles, Oakland, Chicago as well as our online JABSON store at Amazon.com

Subsequent Firm investigation indicates the problem was caused by an oversight in identifying the milk allergen during receiving the seasoning mix.

Product is imported from India where it is manufactured by Bhrigu Foods LLC.  The importers of this product would have been required to have a FSVP in place for this product.  As part of the hazard analysis, allergens will need to be identified as a hazard.  The identification of this could be missed on a less-than-thorough analysis.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/jabsons-foods-pvt-ltd-voluntarily-recalling-five-products-having-tandoori-flavour-due-undeclared
Jabsons Foods PVT LTD is Voluntarily Recalling Five Products Having Tandoori Flavour Due to Undeclared Milk
Summary
Company Announcement Date:  April 19, 2023
FDA Publish Date:  April 19, 2023
Product Type:  Food & Beverages  Gravy/Sauces
Reason for Announcement:  Undeclared milk
Company Name:  JABSONS FOODS PVT LTD
Brand Name:  Jabsons
Product Description:  Chick peas, Peanuts, Peanut Spread, Cashew Nuts

CA Company Recalls Curry Spice After State Lab Finds Undeclared Peanut

Trong Foods International of Santa Ana, CA, is recalling certain of its 4 ounce bottles, 16 ounce bottles, and 4 ounce bags of “Madras Curry Powder” (CA RI NI AN DO “KIM TU THAP”) because they may contain undeclared peanuts.  The recalled “Madras Curry Powder” was distributed within New York State in retail stores and through mail orders and possibly in Maryland, New Jersey, and California. 

The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the peanut-containing product was distributed in packages that did not reveal the presence of peanuts.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/trong-foods-international-issues-allergy-alert-undeclared-peanuts-madras-curry-powder
Trong Foods International Issues Allergy Alert on Undeclared Peanuts in “Madras Curry Powder”
Summary

Company Announcement Date:  April 19, 2023
FDA Publish Date:  April 19, 2023
Product Type:  Food & Beverages  Spices, Flavors & Salts
Reason for Announcement:  Undeclared peanuts
Company Name:  Trong Foods International
Brand Name:  Trong Foods International
Product Description:  Madras Curry Powder (CA RI NI AN DO “KIM TU THAP”)

SD Company Recalls Pretzels for Undeclared Milk

Dakota Style Foods, Inc., of Clark SD, is recalling Hy-Vee Brand Honey Mustard Braided Pretzels, Hy-Vee Brand Dill Pickle Braided Pretzels, and Hy-Vee Brand Salt and Vinegar Braided Pretzels, because it may contain undeclared milk.  The recall was initiated after it was discovered through a consumer complaint that product containing milk was distributed in packaging that did not reveal the presence of milk.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dakota-style-foods-inc-issues-allergy-alert-undeclared-milk-pretzels
Dakota Style Foods, Inc. Issues Allergy Alert on Undeclared Milk in Pretzels
Summary
Company Announcement Date: April 18, 2023
FDA Publish Date: April 18, 2023
Product Type: Food & Beverages
Reason for Announcement: Undeclared Milk
Company Name: Dakota Style Foods, Inc.
Brand Name: Hy-Vee
Product Description: Pretzels

Thursday, April 20, 2023

NC Processor Recalls Blue Crab Dip, Cocktail Sauce, Cole Slaw and Crabcake Due to Undeclared Allergen

Washington Crab, a NC processor, is recalling Blue Crab Dip 8 oz, Cocktail Sauce 8 oz, Cole Slaw 8 oz and 16 oz & Crabcake 2, 6 & 12 Count Packages Due to undeclared allergens.  Products were distributed between Oct 13, 2022 to April 13, 2023. The Blue Crab Dip, Cocktail Sauce and Cole Slaw were packaged in clear plastic cups and Crabcakes on plastic trays and sold primarily to distributors, restaurants and company retail outlet located in the states of North Carolina & South Carolina.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/washington-crab-recalls-blue-crab-dip-8-oz-cocktail-sauce-8-oz-cole-slaw-8-oz-and-16-oz-crabcake-2-6
Washington Crab Recalls Blue Crab Dip 8 oz, Cocktail Sauce 8 oz, Cole Slaw 8 oz and 16 oz & Crabcake 2, 6 & 12 Count Packages Due to Undeclared Milk, Egg, Wheat, Fish & Soy Allergens
Summary
Company Announcement Date:  April 17, 2023
FDA Publish Date:  April 18, 2023
Product Type:  Food & Beverages  Seafood/Seafood Product
Reason for Announcement:  Undeclared egg, fish, milk, soy and wheat
Company Name:  Washington Crab & Seafood Company
Brand Name:  Washington Crab & Seafood Company
Product Description:  Crab dip, cocktail sauce, coleslaw, crabcake

DE Company Expands Recall of Chocolate Crispy Bars for Undeclared Cashew

Wellness Natural USA Inc. of Wilmington, DE is expanding their recall (published Apr 3, 2023) of its SimplyProtein® Peanut Butter Chocolate Crispy Bar, which is sold in a 15-count variety pack that contains two other flavors, because it may contain undeclared cashews. The initial recall which included a single lot has been expanded to include all lots within expiration, the Best Before dates are indicated below.  The recall was voluntarily initiated due to a consumer complaint, which is the only reported reaction to date. It was determined the product may potentially contain undeclared cashew. The expansion comes following a decision by Wellness Natural USA Inc. to exercise an abundance of caution while the root cause of the contamination continues to be investigated.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wellness-natural-usa-inc-expands-allergy-alert-undeclared-cashews-simplyproteinr-peanut-butter
Wellness Natural USA Inc. Expands Allergy Alert on Undeclared Cashews in SimplyProtein® Peanut Butter Chocolate Crispy Bars
Summary
Company Announcement Date:  April 11, 2023
FDA Publish Date:  April 12, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared tree nuts (cashew)
Company Name:  Wellness Natural USA Inc.
Brand Name: SimplyProtein
Product Description:  Peanut Butter Chocolate Crispy Bar

Imported Udon Noodles Recalled Due to Undeclared Fish Allergen

Wismettac Asian Foods, Inc., Santa Fe Springs, CA is recalling 19.04 oz packages of Shirakiku brand Ajhei Sanuki Udon Noodle for undeclared allergen of fish, specifically skipjack tuna.  The recall was initiated after we found out that the product contains undeclared allergen (skipjack tuna: fish). Subsequent investigation indicates the problem was caused by a human error during the label design making process.  The product was imported from Japan.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wismettac-asian-foods-issues-allergy-alert-undeclared-fish-skipjack-tuna-udon-noodle
Wismettac Asian Foods Issues Allergy Alert on Undeclared Fish (Skipjack Tuna) in Udon Noodle
Summary
Company Announcement Date:  April 12, 2023
FDA Publish Date:  April 12, 2023
Product Type:  Food & Beverages
Reason for Announcement: Undeclared fish
Company Name:  Wismettac Asian Foods, Inc.
Brand Name:  Shirakiku
Product Description:  Ajhei Sanuki Udon Noodle

Tuesday, April 11, 2023

Update on Hepatitis A Outbreak Linked to Frozen Organic Strawberries - Additional Companies Issue Recalls

CDC and FDA updated the information on a the Hepatitis A outbreak associated with frozen organic strawberries from a supplier in Baja California, Mexico.  To date, there have been 7 reported cases from 2 states with 2 of those cases resulting in hospitalizations.

Product recalls began for one company, California Splendor, on March 16, 2023.  "In response to this investigation, Scenic Fruit Company of Gresham, Oregon voluntarily recalled frozen organic strawberries, sold to Costco, Trader Joe’s, Aldi, KeHE, Vital Choice Seafood, and PCC Community Markets in certain states."

https://www.cdc.gov/hepatitis/outbreaks/2023/hav-contaminated-food/index.htm
Multistate Outbreak of Hepatitis A Virus Infections Linked to Frozen Organic Strawberries
At a Glance
Reported cases: 7
States: 2
Hospitalizations: 2
Deaths: 0

Outbreak Information
As of April 7, 2023, there are:
  • 7 outbreak-associated cases of hepatitis A reported from 2 states (California and Washington).
  • Illnesses started on dates ranging from November 24, 2022, to March 26, 2023.
  • 2 people have been hospitalized. No deaths have been reported.
  • Epidemiologic and traceback evidence indicate that frozen organic strawberries are the likely source of this outbreak.

Monday, April 10, 2023

FSIS Issues Health Alert for Salad Items After Supplier Recalls Lettuce for Listeria

USDA-FSIS is issuing a public health alert for ready-to-eat (RTE) fresh salad products with chicken and ham that contain Food and Drug Administration (FDA) regulated lettuce that has been recalled for possible Listeria monocytogenes (Lm) contamination.  The problem was discovered when the firm notified FSIS that they used FDA-recalled lettuce to produce the fresh salad with chicken and ham products.  Recalled items, produced by Russ's Commissary of Holland MI,  were shipped to retail locations in Illinois, Indiana, Kentucky, Michigan, Ohio, Tennessee, and Wisconsin.

While not directly stated, the lettuce was likely produced by Revolution Farms, an indoor farm in MI, that just had issued a recall.


https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-fresh-salads-chicken-and-ham-containing-lettuce
FSIS Issues Public Health Alert for Fresh Salads With Chicken and Ham Containing Lettuce Recalled by FDA for Possible Listeria Monocytogenes Contamination
RUSS' COMMISSARY

FSIS Announcement

WASHINGTON, April 7, 2023 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for ready-to-eat (RTE) fresh salad products with chicken and ham that contain Food and Drug Administration (FDA) regulated lettuce that has been recalled for possible Listeria monocytogenes (Lm) contamination.

Salad Produced in GA Facility Recalled After Testing of Product Finds Listeria

Fresh Express Incorporated is recalling a limited quantity of three varieties of already-expired branded and private label salad kit products produced at the company’s Morrow, Georgia facility out of an abundance of caution due to a possible health risk from Listeria monocytogenes.  The recall was initiated when it was learned a random sample test of a single salad kit with a Use-By Date of March 31, 2023 collected by the Georgia Department of Agriculture yielded a positive result for the Listeria pathogen.

Product was distributed through retailers in the states of Florida, Georgia, North Carolina, South Carolina and Virginia.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresh-express-incorporated-announces-precautionary-recall-expired-fresh-salad-kits-due-potential
Fresh Express Incorporated Announces Precautionary Recall of Expired Fresh Salad Kits Due to Potential Health Risk
Summary
Company Announcement Date:  April 07, 2023
FDA Publish Date:  April 07, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Listeria monocytogenes
Company Name:  Fresh Express Incorporated
Brand Name:  Fresh Express & Publix
Product Description:  Salad Kits

Thursday, April 6, 2023

MI Indoor Farm Recalls Products Due to Potential Listeria Contamination

Recall Expanded (FDA April 7, 2023) to include additional products.

Revolution Farms of Caledonia, Michigan is voluntarily recalling the listed products packed between 3/3/23 and 3/11/23, because they have the potential to be contaminated with Listeria monocytogenes.  The recall was initiated when the Michigan Department of Agriculture and Rural Development (MDARD) received a positive result for Listeria monocytogenes in a random sample test of a single package of Revolution Farms Green Sweet Crisp – 5oz Retail with Best By date of April 2, 2023.  To date, there have been no illnesses.

The recalled products were sold to the following retailers and food service distributors in the states of MI, OH, IN, IL, KY, and WI

Revolution Farms is indoor farm, falling in the realm of CEA, or Controlled Environment Agriculture.
"The term controlled environment agriculture (CEA) encompasses a variety of systems that take a technology-based approach to farming. CEA can range from simple shade structures and hoop houses through greenhouses to full indoor or vertical farms. The most advanced systems are fully automated, closed loop systems with controlled lighting, water and ventilation. CEA also encompasses common practices such as plastic film over field-grown crops, nets or shade structures and aquaponics systems that integrate fish or aquaculture with plant production."

"CEA systems are designed to provide optimal growing conditions for crops and prevent disease and pest damage. In indoor systems with artificial lighting, crops may be grown hydroponically, in which roots are bathed in nutrient-dense water, or aeroponically where roots are regularly misted with water and nutrients". (Source UC Davis)
Closed farming systems may pose more Listeria risk than conventional farms.  These environments are not much different than a wet processing facility.  As an example, in 2021, Old Soul's Farms had a Listeria-related recall that linked to Listeria build-up in the rainwater-capture holding tanks.  

Other facilities have had issues with different pathogens including Salmonella and pathogenic E.coli.  Because of these issues, CEAs must address pathogen hazards through risk assessment and enacting preventive controls where needed and verifying GMP type controls, especially if these facilities contain a transition to 'processing' within the scope of their operations.

Interesting note that today, an article appeared in Food Safety Magazine (Apr-May, 2023), "Is CEA a Safer Way to Grow and Process RTE Vegetables? "  The article is not overly insightful in terms of providing a broad perspective of risk, but it does provide these quotes by the author that are interesting... 
  • "Unfortunately, my experience with CEA practitioners is not encouraging with regard to risk mitigation efforts. In my view, CEA growers assume that because they do not have dirt and are enclosed, they are safe. This attitude seems similar to the prevailing attitudes in 2006."
  • "Most, if not all, traditional RTE operations are cold, wet environments. Listeria monocytogenes is of particular concern. Salmonella is generally of greater concern in drier operations. Given that CEA operations can have both wet and dry areas, it is reasonable to consider the development of tailored environmental monitoring programs that address both hazards."
  • "Control of the wash system in a traditional RTE processing facility is an important focus of the food safety program. Washing value-added product has reduced illnesses. CEA, however, has largely bypassed the washing step. Some CEA operations are grappling with the decision to wash or not wash. A handful of operations are washing as a point of differentiation. Since 2006, the science and technology behind washing RTE product have advanced tremendously. Each CEA operation must consider how the safety of its system compares to the current standards of the RTE industry as a whole to support its claims of safety."
  • "CEA farming presents some unique food safety challenges that traditional operations do not face. The recycling of nutrition solutions as part of irrigation has the potential to contaminate an entire production facility. Given the tendency toward continuous production, there are no discrete lots or clean breaks when a problem occurs."
  • "Food safety needs to be designed into operations. The current designs of CEA operations are tailored for optimum operational performance. These designs will evolve in the same way that traditional process plants evolved. Traditional operations are no longer packing sheds. This evolution has taken time. However, given the achieved safety in traditional operations, CEA operations will need to evolve faster and make fewer mistakes."
And finally this regarding the ability to do a good risk assessment:
  • "Unfortunately, the ability to execute a complete risk assessment is still evolving. The standards for risk assessments in the traditional RTE sector are soft. Third-party audits are very prescriptive and often focus on minor details without addressing the fundamentals that must be improved to advance food safety. Given the developmental stage of CEA, it will be difficult to execute a complete risk assessment of CEA operations at present. I expect someone will attempt a risk assessment of a farm in an RTE plant in the near future. It will probably be denounced and attacked; however, it will provide a starting point for a much-needed effort."


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/revolution-farms-announces-voluntary-recall-lettuce-because-possible-health-risk
Revolution Farms Announces the Voluntary Recall of Lettuce Because of Possible Health Risk
Summary
Company Announcement Date:  April 05, 2023
FDA Publish Date:  April 05, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Listeria monocytogenes
Company Name:  Revolution Farms
Brand Name:  Multiple brand names
Product Description:  Lettuce & Salad Kits

Wednesday, April 5, 2023

Popped Water Lilly Seeds Recalled for Undeclared Milk

Karma Spices and Trading Company, LLC of Walled Lake, Michigan is recalling White Cheddar Cheese Popped Water Lily Seeds, because it may contain undeclared Milk.  The recalled White Cheddar Cheese Popped Water Lily Seeds were sold at retail stores in Michigan stores and online at www.karmawellnesskitchen.com.  The recall was initiated after it was discovered that product containing Milk was distributed in packaging that did not list “Contains:Milk” as a common allergen.
Yes, the cheddar cheese is a milk product.

So what is a popped water lily seed?  It is a snack derived from the seeds of the white lily plant, a native to Eastern Asia.  Seeds are collected and then roasted over high heat.  The high heat makes them 'pop'.  Some call these a super food in that it is high in protein and minerals such as magnesium and potassium.  

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/karma-spices-and-trading-company-llc-issues-allergy-alert-undeclared-milk-white-cheddar-cheese
Karma Spices and Trading Company, LLC Issues Allergy Alert on Undeclared Milk in White Cheddar Cheese Popped Water Lily Seeds
Summary
Company Announcement Date:  April 05, 2023
FDA Publish Date:  April 05, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk
Company Name:  Karma Spices and Trading Company, LLC
Brand Name:  Karma
Product Description:  White Cheddar Cheese Popped Water Lily Seeds

MI Cheese Producer Issued Warning Letter for Food Safety Plan Misses That Led to 2022 Listeria Outbreak

FDA issued a Warning Letter to Old Europe Cheese, a Michigan cheese producer.  The inspection was prompted by a 2022 Listeria outbreak linked to their cheese where six (6) ill people from six (6) states were infected with the outbreak strain of L. monocytogenes.

Here is a summary of that report highlighting the big misses that occurred within the Company's Preventive Control Program.  This is an excellent example why a proper Food Safety Plan is needed.
  • Presence of Outbreak Strain of Listeria "FDA collected samples (environmental swabs) of the production environment and confirmed that (1) swab collected from a hole in the (b)(4) floor was positive for L. monocytogenes.  WGS analysis was conducted of the above referenced L. monocytogenes isolate and it was determined that the environmental isolate matched the six (6) clinical isolates that were part of an illness outbreak cluster.
  • Presence of Listeria Indicator Organisms - In addition to L. monocytogenes, the presence of Listeria innocua (L. innocua) was also found in your facility during the FDA environmental swabbing that occurred on September 13 and 14, 2022. L. innocua was detected in two (2) environmental swabs taken from the floor in the (b)(4) Room and a floor drain between the (b)(4) Room and (b)(4) Hallway where the cheese products are RTE (post-pasteurization) and exposed to the environment. The presence of non-pathogenic Listeria species suggests that conditions are suitable for survival and/or growth of L. monocytogenes which, as noted above, has been found in your facility.
  • Hazard Analysis Does Not Consider Environmental Contamination by Pathogens a Significant Hazard - "The "hazard analysis for soft and semi-soft cheese products determined that “Post-Pasteurization Contamination” did not require a preventive control because it was “Unlikely to occur as purity plating of production samples is performed and plant performance history indicates good process control.” In addition, your hazard analysis determined that “Environmental Contamination (Listeria)” did not require a preventive control because an “Environmental program is in place to test for listeria spp. Finished product testing is also performed with positive release program.” However, RTE soft and semi-soft cheese products manufactured in your facility were exposed to the environment at various post-pasteurization processing steps (e.g., (b)(4))"
  • Hazard Analysis Does Not Consider Finished Product Cooler Temperature as a Process Preventive Control - "Hazard analysis did not require a preventive control at the “Cooler Storage” step because a “Program for Cooler Temperature [sic] Control is in place. Plant does not have a history of problematic room temperatures.” However, if not properly time/temperature-controlled, the RTE soft and semi-soft cheese products stored in your facility are likely to support the growth and toxin formation of bacterial pathogens (such as ingredient-related pathogens either surviving pasteurization or added post-pasteurization, or environmental pathogens introduced in your facility). "
    • Deviation to Cooler Temperature - "Through record review during the inspection, we detected two (2) dates where temperatures were recorded as 51.2°F, 52°F and 53.1°F with no record of a corrective action documented. Soft cheeses can support the growth of pathogens, including L. monocytogenes, when not stored at proper refrigeration temperatures."
  • The Hazard Analysis Does Not Properly Address Post-Process Ingredient Additions with Supply Chain Preventive Controls  - The "hazard analysis for soft and semi-soft cheese products determined that bacterial pathogens in many ingredients added after pasteurization (e.g., peppercorns, 1/8” flaked tomato, chives, basil, garlic salt, and parsley) did not require a preventive control because “Product is tested for Salmonella – COA Received per lot.” These ingredients did not undergo a kill step in your facility. A knowledgeable person manufacturing/processing food in your circumstances would identify bacterial pathogens as a hazard requiring a preventive control (i.e., supply-chain program)."
  • Sanitation Procedures Not Fully Implemented - with respect to the production of soft cheeses when they are RTE (post-pasteurization). For example:
    • The "sanitation procedures, as described in the document titled, “GMP Manual,” instructed employees to wash their hands “following practices that may compromise hand cleanliness.” However, on September 13, 2022, our investigators observed two (2) different employees’ hands come into contact with unclean surfaces (e.g., a hose that had been in contact with the floor); these employees (b)(4) their hands into a (b)(4) and returned directly to handling RTE brie cheese without washing their hands."
    • The "Master Sanitation Schedule directed employees to clean-in-place (CIP) the brie vats with both (b)(4) solution according to the production schedule. However, our investigators observed during the CIP on September 15, 2022, that the vat was only filled to approximately (b)(4) of its volume, which resulted in the food-contact surfaces inside not being fully submerged, as would be needed to facilitate effective cleaning. One of your employees also indicated that (b)(4) solution is not always used in the vats during the week, contrary to the instructions in the Master Sanitation Schedule."
  • Not Following the Environmental Monitoring Program - "Environmental Swabbing program required collection of a minimum of (b)(4) samples from designated zone 2-4 locations every (b)(4). However, you collected ten (10) swabs on or around May 25, 2022, and then you stated that you did not collect any more swabs until the week of this inspection, on or around September 14, 2022."
  • Improper Cleaning - "did not conduct cleaning and sanitizing of utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 117.35(a). Specifically, on September 13, 2022 employees were observed spraying the outside of brie vats and the floor around the vats with a hose in such a manner that spray from the hose was observed contacting the floor and subsequently contacting the adjacent cheese molding machine."
  • Condensation Issues - "Condensation was observed throughout the facility including on areas above cheese molding equipment and RTE brie cheese. For example, condensation and dark reddish-brown stains were observed on the ceiling directly over at least ten racks of stacked food-contact cheese molds stored in the Clean Room. Clear condensation was also observed on pipes and the ceiling within two feet of exposed RTE brie cheese in (b)(4) Room (b)(4). Condensation was also visible on the walls and windows near the ceiling of the (b)(4) Room where food-contact cheese molds were observed sitting on racks exposed to the environment in this room for approximately three hours before being moved to the (b)(4) Room."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/old-europe-cheese-inc-644539-03172023
WARNING LETTER

Tuesday, April 4, 2023

Eyedrops Recalled Due to Contamination Leading to Severe Eye Infections, 483 Report Details QC Horrors At Foreign Manufacturer

Global Pharma Healthcare recalled all lots of their Artificial Tears Lubricant Eye Drops, distributed by /EzriCare, LLC- and Delsam Pharma, due to possible contamination.  This product was identified by CDC as the source of "Pseudomonas aeruginosa (VIM-GES-CRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare. To date, there are 55 reports of adverse events including eye infections, permanent loss of vision, and a death with a bloodstream infection."

The 483 Report (obtained from www.marlerblog.com) details an extremely bad operation.  
(https://www.marlerblog.com/files/2023/04/Global-Pharma-Healthcare-Ltd.-Tamilnadu-India-3.2.23-483.pdf)

This is an imported product.  We often wonder why some items are less expensive than branded products that are produced in the US.  Products produced in the US have to meet established sanitary standards.   

Observations from the report include:

Obs 1A.  Lack of validation support for demonstrating the equipment can be reliably sterilized.  And with that, the procedures were not followed for the required sterility filters.
Obs 1B. Improper filter testing
Obs 1C. Did not perform container closure integrity test adequately.
Obs 1D. Formulation not followed, specifically with inadequate preservatives.
Obs 1E Aseptic process lacked sterility assurance
Obs 1F. Airflow patterns insufficient (to demonstrate air control in aseptic environment)
Obs 1G Floors, walls, and ceilings were not appropriate for aseptic processing - cracks, holes, etc
Obs 1H Employees not qualified, did not follow appropriate procedures for aseptic environment.

Obs 2 - Test methods not established for accuracy, sensitivity, and reproducibility.
Obs 3 - Equipment does not have appropriate deisgn for how it is being used.
Obs 4 - Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic products.  Including (C) surfaces that contact the container closures is not cleaned.
Obs 5 - Failed to conduct test to verify identity of each component of the eye products.
Obs 6 - Failed to establish written procedures for cleaning and maintaining the equipment.



Obs 7 - Defient environmental monitoring.
Obs 8 - Laboratory controls  do not have specifications for conformance - what is acceptable.
Obs 9 - REcord reviews not completed and approved by QC 
Obs 10 - Stability samples not stored according to written procedures
Obs 11 - QC does not have responsibility and authority to approve, reject.

Yikes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/global-pharma-healthcare-issues-voluntary-nationwide-recall-artificial-tears-lubricant-eye-drops-due
Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant Eye Drops Due to Possible Contamination
Summary
Company Announcement Date:  February 02, 2023
FDA Publish Date:  February 02, 2023
Product Type:  Drugs
Reason for Announcement:  Potential microbial contamination
Company Name:  Global Pharma Healthcare
Brand Name:  EzriCare & Delsam Pharma
Product Description:  Artificial Tears Lubricant Eye Drops

Monday, April 3, 2023

CDC - Salmonella Outbreak Linked to Flour - Investigation Notice 3-30-23

CDC and State partners are investigating a Salmonella outbreak that has been linked to raw flour. As of March 30, 2023, 12 people infected with the outbreak strain of Salmonella have been reported from 11 states (see map). Illnesses started on dates ranging from December 6, 2022, to February 13, 2023 (see timeline).

While an exact source is yet to be identified, it is important to follow proper practices when handling raw flour.
  • Do not eat raw dough or batter.
  • Clean surfaces and utensils that have residual raw flour with warm water or soap.
  • Wash hands after handling raw flour, dough, or batter.
  • Handle raw flour in a way that prevents it from cross contaminating surfaces that will not be cleaned immediately.
  • Store raw flour properly, preventing it from getting over other surfaces or food.
Salmonella Outbreak Linked to Flour
https://www.cdc.gov/salmonella/infantis-03-23/index.html
Fast Facts
Illnesses: 12
Hospitalizations: 3
Deaths: 0
States: 11
Recall: No
Investigation status: Active

FDA Issues Warning Letter to CA Seafood Processor for Salmonella Contamination

FDA issued a Warning Letter to a CA seafood processing operation after an inspection was initiated as part of a multistate foodborne outbreak investigation of Salmonella Litchfield (S. Litchfield) infections linked to seafood, including fresh, raw salmon, supplied by the facility.  "According to the Centers for Disease Control and Prevention (CDC), 39 people from 4 states were infected with the outbreak strain of S. Litchfield. "

"FDA laboratory analyses found the presence of the outbreak strain of S. Litchfield and two additional Salmonella strains, Salmonella Mbandaka (S. Mbandaka) and Salmonella Oranienburg (S. Oranienburg), which are human pathogens, in [the] facility. On October 20, 2022, [the] firm recalled various types of fresh fish processed at [the] facility and distributed between June 14, 2022 and October 17, 2022, because they had the potential of being contaminated with Salmonella. FDA and CDC have determined, based upon the epidemiologic, traceback evidence, and whole genome sequencing (WGS) matches between clinical and FDA environmental samples, that fresh salmon processed at [the]  facility was the likely source of this multistate S. Litchfield outbreak"

Salmonella was found throughout the facility, which indicates poor sanitation among other poor practices.  Even though this is raw fish, Salmonella should not be present.
"Salmonella species are not endemic to seafood; therefore, FDA expects zero or non-detectable levels of Salmonella in seafood regardless of whether it is intended to be cooked before consumption or it is ready-to-eat (RTE). Salmonella in seafood is the result of human or animal fecal contamination of the harvest waters and/or fecal contamination during post-harvest handling and processing. The contamination can also be exacerbated by temperature abuse. Raw RTE seafood must have appropriate controls from harvest to consumption."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mariscos-bahia-inc-646401-02072023
WARNING LETTER

Mariscos Bahia, Inc.
MARCS-CMS 646401 — FEBRUARY 07, 2023

FDA Issues Warning Letter to Salad Dressing Bottler After Recall for Mislabeling

FDA issues a Warning Letter to Vanlaw Food Products after their Whole Foods 365 Organic Creamy Caesar Dressing sold in 10 fl. oz. clear glass bottles was mislabeled with the finished product back label having Classic Ranch Dressing and Dip and thus not declaring major food allergens, wheat and soy.
The company had similar recalls.  
  • One being on September 19, 2022, where the expanded this recall after being notified by the customer of another lot of 365 Organic Creamy Caesar mislabeled with 365 Organic Classic Ranch Dressing and Dip back panel ingredient labels that do not declare wheat and soy. 
  • On April 4, 2022, 365 Organic Creamy Caesar Dressing was recalled because of an incorrect back panel for Whole Foods Market Organic Blue Cheese applied to the product, which did not declare the allergens of wheat and soy
This is a pretty easy problem to fix if utilizing a properly designed Allergen Preventive Control for label application.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vanlaw-food-products-inc-641010-01052023
Vanlaw Food Products, Inc
MARCS-CMS 641010 — JANUARY 05, 2023
Recipient:
Mr. Pablo Gallo Llorente
President
Vanlaw Food Products, Inc
1851 North Delilah St.
Corona, CA 93879
United States

CR - 10 Risky Recalled Foods

Consumer Reports lists the 10 Foods Linked to Serious Recalls and Outbreaks and provides an explanation why each ended up there. They also provide some practical handling procedures
  1. Leafy Greens
  2. Cheeses and Deli Meat
  3. Ground Meat 
  4. Onions
  5. Turkey
  6. Chicken
  7. Papayas
  8. Peaches
  9. Cantaloupe
  10. Flour
While we can argue about what should be in the Top Ten, the information provided in this report is okay. 
The danger of any list like this is that people will avoid products because it is on 'the list'.   Onions for example...one should not avoid using onions, but follow practical handling procedures.  On the avoidance of pre-cut fruit...certainly if you are extremely risk averse, you would want to avoid pre-but fruit, otherwise, the overall risk is small when purchasing from a reputable producer.

A much better write-up than done in the past by this organization.

Chocolate Bars From Costco Recalled Due to Undeclared Tree Nuts - Cashews

Wellness Natural USA Inc. of Wilmington, DE is voluntarily recalling a single lot of its SimplyProtein® Peanut Butter Chocolate Crispy Bar in the United States, which is sold in a 15-count variety pack that contains two other flavors, because it may contain an undeclared trace of tree nuts (cashews).   The recalled products were distributed in the United States in limited Costco stores in Arkansas, California, Washington DC, Kansas, Maryland, Oklahoma, Pennsylvania, Texas and Virginia.  The recall was voluntarily initiated due to a consumer complaint, which is the only reported reaction to date, and a determination that the lot may have the potential to contain trace levels of undeclared cashew. The cause of the contamination is being investigated.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wellness-natural-usa-inc-issues-allergy-alert-undeclared-cashews-simplyproteinr-peanut-butter
Wellness Natural USA Inc. Issues Allergy Alert on Undeclared Cashews in SimplyProtein® Peanut Butter Chocolate Crispy Bars
Summary
Company Announcement Date:  March 31, 2023
FDA Publish Date:  April 03, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared tree nuts (cashew)
Company Name:  Wellness Natural USA Inc.
Brand Name:  SimplyProtein
Product Description:  Peanut Butter Chocolate Crispy Bar

FL Company Recalls Smoked Salmon After State Testing Finds Listeria

Seven Seas International USA, LLC of St. Petersburg, Florida is voluntarily recalling 295 cases of Biltmore Smoked Sockeye Salmon with production lot R4058 because Listeria monocytogenes may be present in some product. The issue was discovered through routine regulatory testing conducted by the Florida Department of Agriculture and Consumer Services.  This product was distributed through Publix Supermarket.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/seven-seas-international-usa-llc-voluntarily-recalling-biltmore-smoked-sockeye-salmon-because
Seven Seas International USA, LLC is Voluntarily Recalling Biltmore Smoked Sockeye Salmon Because of Possible Health Risk
Summary
Company Announcement Date:  March 14, 2023
FDA Publish Date:  March 31, 2023
Product Type:  Food & Beverages  Fish
Reason for Announcement:  Potential Foodborne Illness/Listeria
Company Name:  Seven Seas International USA, LLC.
Brand Name:  Biltmore
Product Description:  Biltmore Smoked Wild Sockeye Salmon
Company Announcement  Date: March 14, 2023

Illinois Food Company Recalls Hamburger Skillet Meal After Mispacking Results in Undeclared Milk

Gilster Mary Lee, an  Illinois food company, is recalling one lot of HyVee Hamburger Chili Macaroni Skillet Meal, UPC 75450-08552 at the consumer level because it may contain undeclared milk.  Missouri, Kansas, Nebraska, South Dakota, Minnesota and Wisconsin. Gilster-Mary Lee Corp. became aware of the mispackaging after receiving an email from a customer. No illnesses have been reported to date in connection with this product.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gilster-mary-lee-corp-issues-recall-undeclared-milk-allergen-hyvee-hamburger-chili-macaroni-skillet
Gilster-Mary Lee Corp. Issues a Recall for Undeclared Milk Allergen in HyVee Hamburger Chili Macaroni Skillet Meal
Summary
Company Announcement Date:  March 28, 2023
FDA Publish Date:  March 29, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Milk Allergen
Company Name:  Gilster-Mary Lee Corp.
Brand Name:  HyVee
Product Description:  Hamburger Chili Macaroni Skillet Meal

CA Distributor Recalls Sauces Due to Undeclared Soy

A California food distributor is recalling imported Worcester Sauce and Chuno Sauce due to undeclared soy on the label. The recall was initiated after it was discovered that product containing Soy was distributed in packaging that did not reveal the presence of Soy allergen

It seems that the Fermented Seasoning would be the source of the soy.





https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/north-american-food-distributing-company-inc-issues-allergy-alert-undeclared-soy-169-fl-oz-kagome
North American Food Distributing Company, Inc. Issues Allergy Alert on Undeclared Soy in 16.9 Fl Oz of Kagome Worcester Sauce and 16.9 Fl Oz of Kagome Chuno Sauce
Summary
Company Announcement Date:  March 28, 2023
FDA Publish Date:  March 29, 2023
Product Type: Food & Beverages  Gravy/Sauces
Reason for Announcement:  Undeclared Soy
Company Name:  North American Food Distributing Company, Inc.
Brand Name:  Kagome
Product Description:  Worcester Sauce; Chuno Sauce

FL Company Recalls Dark Chocolate Bites for Undeclared Milk

Salento Organics of West Palm Beach, Florida is recalling its 4 ounce packages of Dark Chocolate Pitaya Bites, Dark Chocolate Goldenberry Bites, Dark Chocolate Mango Bites, Dark Chocolate Banana Bites, Dark Chocolate Pineapple Bites and Dark Chocolate Peanut Bites because they may contain undeclared milk.  The recall was initiated after it was discovered that the milk-containing product was distributed in packaging that did not reveal the presence of milk.  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/salento-organics-issues-allergy-alert-undeclared-milk-dark-chocolate-fruit-and-peanut-bites
Salento Organics Issues Allergy Alert on Undeclared Milk in Dark Chocolate Fruit and Peanut Bites
Summary
Company Announcement Date:  March 29, 2023
FDA Publish Date:  March 29, 2023
Product Type:  Food & Beverages   Snack Food Item
Reason for Announcement:  Undeclared Milk
Company Name:  Salento Organics
Brand Name:  Salento Organics
Product Description:  Various Dark Chocolate Fruit and Peanut Bites

Seafood Related Toxins and Scombrotoxin - US Cases

FDA released its updated table on Seafood-Related Toxin and Scombrotoxin Fish Poisoning Illnesses. The table shows "natural toxin illness and outbreak incidents that are no longer active. These incidents have been reported to and managed by the FDA."

What a great opportunity to review these toxins and introduce a new one (at least for me) Haff disease.

Ciguatera Fish Poisoning (CFP)
  • Commonly related to the consumption of subtropical and tropical reef fish which can accumulate naturally occurring ciguatoxins through their diet  Fish can include - barracuda; grouper; snapper; jacks and trevally; wrasse; mackerel; tang; moray eels; and parrotfish
  • The onset of symptoms typically occurs within 6 hours after consuming toxic fish and may persist from several days to weeks. In severe cases, some neurological symptoms may persist for months and can recur for years.
  • The neurological symptoms are what sets this apart as foodborne illness - Numbness and tingling of the lips and extremities; Itching of the hands and feet; Joint pain; Muscle pain; Muscle weakness; 
  • Reversal and sensitivity to temperature; Dizziness; and Vertigo;
Scombrotoxin Fish Poisoning (SFP)
  • Caused by histamine formation as a result of time and temperature abuse such as improper storage/refrigeration of certain types of fish can cause consumer illness. 
  • Primarily associated with the consumption of tuna, mahi-mahi, marlin, and bluefish, among other species when those species have been temperature abused somewhere in the supply chain (from the point of catch to the point of cooking.
  • Symptoms usually occur within a few minutes to a few hours of consumption and last from 12 hours to a few days. Symptoms of SFP include: Tingling or burning in or around the mouth or throat; Rash or hives on the upper body; Drop in blood pressure; Headache; Dizziness; Itching of the skin; Nausea; Vomiting; Diarrhea; Asthmatic-like constriction of the air passage; Heart palpitations; and Respiratory distress  (basically a allergic-type response)

Puffer Fish Poisoning (PFP)

  • Caused by naturally occurring tetrodotoxin is associated with the consumption of puffer fish from waters of the Indo-Pacific Ocean Regions, Gulf of Mexico, Gulf of California, and specific areas on the Atlantic coast of Florida
  • Symptoms usually develop within 3 hours after consumption of contaminated fish and may last from 24 – 48 hours. Death commonly occurs due to muscle paralysis resulting in respiratory failure when ventilatory support is not accessible.

Seafood-associated Rhabdomyolysis or Haff disease  (HAFF)
  • Linked to the consumption of buffalo fish in the United States although other fish species such as burbot, crayfish, eel, pike and salmon have been associated with the disease worldwide.  Buffalo fish are these carp like fish that can be easily confused with carp.
  • Results in the breakdown of skeletal muscle (rhabdomyolysis), with a risk of acute kidney failure that develops within 24 hours after consuming certain fish. Initial symptoms include muscle tenderness and weakness, sometimes with tea-colored urine.
  • It is suspected that it is  caused by a bioaccumulation of a new, heat-stable freshwater and/or brackish/saltwater algal toxin, similar to palytoxin but primarily myotoxic and not neurotoxic.


Table continues - How to Report Seafood-Related Toxin and Scombrotoxin Fish Poisoning Illnesses | FDA

Wednesday, March 29, 2023

FDA Warning Letter - FL Catering Company with History of Listeria

FDA issued a Warning Letter to Wise Spice Catering Company, of Hialeah, Florida, a facility producing ready-to-eat (RTE)  products including sandwiches and meals.

Listeria in facility and in product
  • FDA "found that nineteen (19) swabs were confirmed positive for L. monocytogenes. Of the positive findings, one (1) swab was collected from the food-contact surface of a prep table in the (b)(4) Room used in the assembling of your RTE closed faced sandwiches, and one (1) swab was collected from the food-contact surface of a black milk crate holding raw tomatoes and onion used in RTE closed faced sandwiches and salads. This was not the first time L. monocytogenes was found in environmental samples collected in your facilities building. In 2020, FDA detected L. monocytogenes in six (6) environmental swabs; in 2018, FDA detected L. monocytogenes in nine (9) environmental swabs; and in 2017 FDA detected L. monocytogenes in eighteen (18) environmental swabs."
  • "Based on the results of the WGS analysis, these isolates represent eighteen (18) different strains of L. monocytogenes. The WGS analysis identified multiple strains of L. monocytogenes isolated over multiple years which is indicative of the presence of resident pathogens or harborage sites in your facility."
  • Many of these strains were found in different product samples tested since 2015.
GMP issues
  • Ineffective measures to exclude pests from  packing and holding areas with sightings of cockroaches and flies.
  • Drip / condensate falling from from fixtures, ducts and pipes 
  • Improper cleaning including the use of unclean utensils
  • Inadequate temperatures control
As of this issuance, the company looks to be be permanently closed.


https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wise-spice-catering-company-640715-03082023
FDA Warning Letter - Wise Spice Catering Company

Mammoth Meatballs...Potential for the Real Deal Paleo Diet

An Australian company created mammoth meatballs from meat grown from cells with "DNA sequence from mammoth myoglobin, a key muscle protein in giving meat its flavour, and filled in the few gaps using elephant DNA."  "This sequence was placed in myoblast stem cells from a sheep, which replicated to grow to the 20bn cells subsequently used by the company to grow the mammoth meat."

"No one has yet tasted the mammoth meatball. “We haven’t seen this protein for thousands of years,” said Wolvetang. “So we have no idea how our immune system would react when we eat it. But if we did it again, we could certainly do it in a way that would make it more palatable to regulatory bodies.”"


The Guardian
https://www.theguardian.com/environment/2023/mar/28/meatball-mammoth-created-cultivated-meat-firm
Meatball from long-extinct mammoth created by food firm

Exclusive: Australian company resurrects flesh of lost species to demonstrate potential of meat grown from cells

A mammoth meatball has been created by a cultivated meat company, resurrecting the flesh of the long-extinct animals.

Tuesday, March 28, 2023

FDA Proposed Rule to Allow Salt Substitutes in Standards of Identity

FDA is proposing a new rule that would allow salt substitutes in a products Standards of Identity.  "The amendments would permit the use of safe and suitable salt substitutes to replace some or all of the salt used in the manufacture of standardized foods. The proposed rule would not list specific salt substitutes; instead, the proposed rule would cover ingredients or combinations of ingredients used as salt substitutes by food manufacturers currently or in the future. If finalized, the proposed rule would support efforts to reduce sodium content in standardized foods and may help to improve consumer dietary patterns by reducing sodium consumption."

"The FDA began establishing Standards of Identity (SOI) in 1939, and since then, the agency has established more than 250 SOIs. Products like milk, milk chocolate, various breads, peanut butter, and ketchup have a SOI. SOIs often describe in detail what a food must contain and what is optional and sometimes describe the amount or proportion of ingredients or components. Many SOIs also prescribe a method of production or formulation."

Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods
https://www.fda.gov/media/166473/download

Monday, March 27, 2023

Co-op Grocery Stores - A Shopping Solution for Rural Areas

Many rural counties in teh United States have no grocery store.  To solve this, communities have come together to have co-op stores, or have found other innovative ways.

"The Rural Grocery Initiative was created in 2006 to help establish and sustain grocery stores in rural communities throughout Kansas."  

"Carver said innovation can help keep stores in small towns.  “We've seen success with communities kind of becoming engaged through cooperatives, through public-private partnerships,” Carver said. “We've even seen nonprofits and school-run grocery stores, as well as municipally-run stores in communities.”"


High Plains Public Radio

https://www.hppr.org/hppr-news/2023-03-24/rural-grocery-stores-are-dying-off-heres-what-some-communities-are-doing-to-save-them
Rural areas are losing grocery stores to consolidation faster than their urban counterparts — but some communities have come up with innovative solutions.

Packing in Cans vs Bottles....For Beer Quality

Which stays better longer...beer in a can or in a bottle.  The answer, "researchers report in ACS Food Science & Technology that the answer is, well, complicated, and depends on the type of beer. An amber ale stayed fresher in bottles, whereas container choice made much less difference to the stability of an India Pale Ale (IPA)."

"Cans and brown bottles of amber ale and IPA were chilled for a month and then kept at room temperature for five months to mimic typical storage conditions. Every two weeks, the researchers analyzed the metabolites in newly opened containers. Throughout this time, the concentration of certain metabolites in amber ale — including some amino acids and esters — differed significantly depending on whether it was packaged in a bottle or can. IPA, however, was much less sensitive to packaging type, possibly because of its higher concentration of polyphenols from hops. These compounds not only prevent oxidation but also bind to amino acids, thus retaining them in the beer rather than allowing them to get stuck to the inside of a container."

https://www.acs.org/pressroom/presspacs/2023/march/cans-or-bottles-whats-better-for-a-fresh-stable-beer.html
Cans or bottles: What’s better for a fresh, stable beer?
PressPacs March 20, 2023 8:00 AM EDT

FOR IMMEDIATE RELEASE

ACS Food Science & Technology

The flavor of beer begins to change as soon as it’s packaged, prompting a debate among afficionados: Does the beverage stay fresher in a bottle or a can? Now, researchers report in ACS Food Science & Technology that the answer is, well, complicated, and depends on the type of beer. An amber ale stayed fresher in bottles, whereas container choice made much less difference to the stability of an India Pale Ale (IPA).

Sunday, March 26, 2023

KS Establishment Recalls Boneless Beef Chuck After FSIS Testing Finds E. coli O103 (STEC)

Elkhorn Valley Packing, a Harper, Kan. establishment, is recalling approximately 3,436 pounds of boneless beef chuck product that may be contaminated with Shiga toxin-producing E. coli (STEC) O103.  The problem was discovered when FSIS was conducting routine FSIS testing of ground beef derived from this product and the sample confirmed positive for STEC O103. There have been no confirmed reports of adverse reactions due to consumption of these products.

These items were shipped to distributors, federal establishments, retail locations, and wholesale locations, which includes hotels, restaurants, and institutions, in Connecticut, Illinois, Indiana, Maryland, Massachusetts, Michigan, New Jersey, New York and Pennsylvania.

There have been no confirmed reports of adverse reactions due to consumption of these products.  Many clinical laboratories do not test for non-O157 STEC, such as O103, because it is harder to identify than STEC O157:H7. People can become ill from STECs 2–8 days (average of 3–4 days) after consuming the organism.  Most people infected with STEC O103 develop diarrhea (often bloody) and vomiting. Some illnesses last longer and can be more severe. Infection is usually diagnosed by testing of a stool sample.


https://www.fsis.usda.gov/recalls-alerts/elkhorn-valley-packing-recalls-boneless-beef-chuck-product-due-possible-e--coli-o103
Elkhorn Valley Packing Recalls Boneless Beef Chuck Product Due to Possible E. coli O103 Contamination

ELKHORN VALLEY PACKING LLC

WASHINGTON, March 24, 2023 – Elkhorn Valley Packing, a Harper, Kan. establishment, is recalling approximately 3,436 pounds of boneless beef chuck product that may be contaminated with Shiga toxin-producing E. coli (STEC) O103, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Ala Establishment Recalls Jalapeno Rope Sausage For Allergens After Mislabeling Issue

Kelley Foods, an Elba, Ala. establishment, is recalling approximately 1,455 pounds of smoked baby rope sausage due to misbranding and an undeclared allergen, the product contains cheese, thereby milk, a known allergen, which is not declared on the product label.  The problem was discovered when the firm notified FSIS that a grocery store manager found that the Kelley Foods Jalapeño Pepper Baby Rope Sausage appeared to contain cheddar cheese, which was not listed as an ingredient on the product label. Upon further investigation, the firm confirmed that its jalapeño and cheddar baby rope sausage product contained the wrong label.


https://www.fsis.usda.gov/recalls-alerts/kelley-foods-recalls-smoked-baby-rope-sausage-product-due-misbranding-and-undeclared
Kelley Foods Recalls Smoked Baby Rope Sausage Product Due to Misbranding and an Undeclared Allergen

KELLEY FOODS, A DIVISION OF BEN E. KEITH

FSIS Announcement

WASHINGTON, March 23, 2023 – Kelley Foods, an Elba, Ala. establishment, is recalling approximately 1,455 pounds of smoked baby rope sausage due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains cheese, thereby milk, a known allergen, which is not declared on the product label.

Gluten-free Brownie Bites Recalled for Undeclared Wheat Caused by Co-Manufacturer

Second Nature Brands of Madison Heights, MI, is recalling its 4-ounce packages of Gluten Free Reese’s Pieces Brownie Brittle because they may contain undeclared wheat.  The recall was initiated after it was discovered that the gluten-containing product was distributed in packaging that did not reveal the presence of wheat. Subsequent investigation indicates the problem was caused by cross-contamination at a co-manufacturer, resulting in undeclared wheat in the product.

One illness has been reported to date in connection with this problem, to date.

This is just another issue we have seen where a co-manufacturer has been responsible for allergen-related recalls.  Also, we have a co-branded product here, where a well-known brand is linked to recall.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/second-nature-brands-issues-allergy-alert-undeclared-wheat-gluten-free-reeses-pieces-brownie-brittle
Second Nature Brands Issues Allergy Alert on Undeclared Wheat in Gluten Free Reese’s Pieces Brownie Brittle
Summary
Company Announcement Date:  March 23, 2023
FDA Publish Date:  March 23, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Wheat
Company Name:  Second Nature Brands
Brand Name:  Sheila G’s
Product Description:  Gluten Free Reese’s Pieces Brownie Brittle

IN Bakery Recalls Buns Due to Undeclared Sesame

Perfection Bakeries D/B/A Aunt Millie’s of Fort Wayne, IN. is recalling 8 ct. packages of Our Family® White Hot Dog Buns because they may contain undeclared sesame.  The recall was initiated after it was discovered the sesame-containing product was distributed in packaging that did not reveal the presence of sesame. Production of the product has been suspended until the FDA and Aunt Millie’s complete their investigation and are certain the market has been cleared of any incorrect packaging.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/perfection-bakeries-dba-aunt-millies-issues-allergy-alert-undeclared-sesame-our-family-hot-dog-buns
Perfection Bakeries, d/b/a/ Aunt Millie’s Issues Allergy Alert on Undeclared Sesame in “Our Family Hot Dog Buns 8 Ct.”
Summary
Company Announcement Date:  March 21, 2023
FDA Publish Date:  March 22, 2023
Product Type:  Food & Beverages  Bakery Product/Mix
Reason for Announcement:  Potential or Undeclared Allergen/Sesame
Company Name:  Perfection Bakeries D/B/A Aunt Millie’s
Brand Name:  Our Family
Product Description:  White Hot Dog Enriched Buns

Bird Seed Recalled for Elevated Aflatoxin Levels

Kaytee Products Inc. is voluntarily recalling one lot of Kaytee® Wild Bird Food Birders’ Blend, 8 lb. bag, UPC 0 71859 02711 1, Lot Number PennPak1 102022 933, best buy date of 041224, due to potentially elevated levels of Aflatoxin above the acceptable limit.  On March 13, 2023, the Georgia Department of Agriculture notified Kaytee Products Inc. that after conducting a routine laboratory analysis of the product, Lot PennPak1 102022 933 located on the bottom right corner of the front of the 8 lb. bags of Kaytee® Wild Bird Food Birder’s Blend was found to contain elevated levels of Aflatoxin.

The affected wild bird product was packaged in clear plastic bags and shipped to ACE Hardware Distribution Centers in AL, FL, and GA.

Aflatoxin is a naturally occurring by-product from the growth of Aspergillus flavus and can be harmful to wild birds if consumed in significant quantities.




(White-breasted Nuthatch is disgusted).


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/voluntary-recall-one-lot-kayteer-wild-bird-food-birders-blend-8-lb-bag-due-elevated-levels-aflatoxinVoluntary Recall of One Lot of Kaytee® Wild Bird Food Birders Blend, 8 Lb Bag, Due to Elevated Levels of Aflatoxin
Summary
Company Announcement Date:  March 18, 2023
FDA Publish Date:  March 20, 2023
Product Type:  Animal & Veterinary  Pet Food
Reason for Announcement:  Potential Elevated Levels of Aflatoxin
Company Name:  Kaytee Products Inc.
Brand Name:  Kaytee
Product Description:  Wild Bird Food Birders’ Blend

Sauces Recalled for Undeclared Soy in Derived Ingredient

Mutual Trading Co., Inc. of El Monte, CA is recalling 60 fl oz of Kagome Worcester Sauce, 10 fl oz of Kagome Chuno sauce, and 8g of Kagome Take out Tonkatsu Sauce because the package labels contain undeclared soy allergen.  The recall was initiated after it was discovered that the product containing soy was distributed in packaging that did not declare the presence of soy.  Subsequent investigation indicates the problem was caused by missing to indicate soy from a 2nd derived ingredient.

The most likely item would be the protein hydrolysate, with the protein source being soy.




https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mutual-trading-co-inc-issues-allergy-alert-undeclared-soy-sauces

Monday, March 20, 2023

MA Company Recalls Cereal Bars Contaminated with Tobacco Bettles

Given Imaging Ltd. of Mansfield, MA is recalling Given Imaging SmartBar Cereal Bar due ot the potential for contamination with tobacco beetles (also known as cigarette beetles). These are a common pest to the tobacco products. They will also infest other stored products such as paprika, dry dog food, beans, biscuits, cottonseed, dried fruits and vegetables as well as dried flowers, grains, herbs, peanuts, rice, yeast and even furniture stuffing.  They are not harmful, but can cause damage to the products.


Enforcement Report (fda.gov)


Infant Formula Recalled for Potential Cronobacter sakazaki Contamination

Perrigo Company plc is issuing a voluntary recall of certain lots of Gerber® Good Start® SootheProTM Powdered Infant Formula in the U.S., that were manufactured at the Company’s Gateway Eau Claire, Wisconsin manufacturing facility from January 02, 2023 to January 18, 2023 due  to the potential presence of Cronobacter sakazakii.

The company stated, "Importantly, no distributed product has tested positive for the presence of this bacteria, no adverse events have been reported and no other products manufactured at this facility or any other of Perrigo’s facilities are affected by this recall."

On November 1, 2022, Perrigo acquired Nestlé's Gateway Eau Claire, Wisconsin, plant, along with the U.S. and Canadian rights to the Good Start® infant formula brand. Perrigo operates the Good Start® infant formula brand in the United States and Canada while Nestlé operates the Good Start® infant formula brand for Women Infants and Children (WIC) contracts.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/perrigo-announces-voluntary-recall-limited-quantity-gerberr-good-startr-sootheprotm-powdered-infant
Perrigo Announces Voluntary Recall of Limited Quantity of Gerber® Good Start® SootheProTM Powdered Infant Formula
Summary
Company Announcement Date:  March 17, 2023
FDA Publish Date:  March 17, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Potential Cronobacter sakazakii contamination
Company Name:  Perrigo Company plc
Brand Name:  Gerber Good Start
Product Description:  Powdered Infant formula

Imported Frozen Strawberries Linked to Hepatitis A Outbreak, Product Recalled in HI and CA

California Splendor, Inc. of San Diego, California is recalling certain lots of 4-lb. bags of Kirkland Signature Frozen Organic Strawberries that were sold at Costco stores in Los Angeles, Hawaii and two San Diego business centers, due to an outbreak of Hepatitis A illnesses. The outbreak of hepatitis A linked to frozen organic strawberries imported from certain farms located in Baja California, Mexico, by a common supplier.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updated-scenic-fruit-company-recalls-frozen-organic-strawberries-and-frozen-organic-tropical-blend
Updated - Scenic Fruit Company Recalls Frozen Organic Strawberries and Frozen Organic Tropical Blend Because of Possible Health Risk
Summary
Company Announcement Date:  March 16, 2023
FDA Publish Date: March 17, 2023
Product Type: Food & Beverages
Reason for Announcement: Hepatitis A
Company Name: Scenic Fruit Company
Brand Name: Simply Nature, Vital Choice and others
Product Description: Frozen Organic Strawberries and fruit blend

Beef Sambusa Recalled After Metal Wire Pieces Detected in Product

Hoyo, SBC, a Bloomington, Minn. establishment, is recalling approximately 1,046 pounds of ready-to-eat beef sambusa products that may be contaminated with extraneous materials, specifically thin, wire-like metal.  The frozen, ready-to-eat beef sambusa items were produced on Dec. 30, 2022, and Feb. 21, 2023. The following product is subject to recall.  The problem was discovered when the firm notified FSIS that it received a report from a school that food handlers found thin, wire-like metal on the outside of the product during preparation. The material was not reported to be embedded in the product.

A sambusa - it is a fried (or baked) triangular dough product stuffed with meat, potato and spice.  It is a finger food that originates in the Arabian subcontinent.  


https://www.fsis.usda.gov/recalls-alerts/hoyo-sbc-recalls-frozen-ready-eat-beef-sambusa-product-due-possible-foreign-matter
Hoyo, SBC Recalls Frozen, Ready-To-Eat Beef Sambusa Product Due to Possible Foreign Matter Contamination
HOYO, SBC

FSIS Announcement

WASHINGTON, March 17, 2023 – Hoyo, SBC, a Bloomington, Minn. establishment, is recalling approximately 1,046 pounds of ready-to-eat beef sambusa products that may be contaminated with extraneous materials, specifically thin, wire-like metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Meat-containing Sfihas Products Recalled For Not Being Produced under USDA Inspection

WOW Frozen Food LLC, a Plantation, Fla. establishment, is recalling approximately 488 pounds of meat and poultry sfihas products that were produced without the benefit of USDA federal inspection.  The problem was discovered during routine FSIS surveillance activities when various frozen sfihas meat and poultry products that did not have the USDA mark of inspection were observed at a retail location. Upon further investigation, FSIS determined that the products were not produced in an FSIS-inspected establishment.

From Wikipedia - Sfiha or sfeeha (Arabic: صفيحة, romanized: ṣafīḥa) is a dish consisting of flatbread cooked with a minced meat topping, often lamb flavored with onion, tomato, pine nuts, and spices. It is traditionally found in the countries of the Levant,[1] and is closely related to manakish and lahmacun.[2]  Sfiha has become popular in Brazil and Argentina, where it is known as esfiha or esfirra in Brazil or as sfija in Argentina, after being introduced by immigrants from Syria,Armenia and Lebanon.[3][4]



https://www.fsis.usda.gov/recalls-alerts/wow-frozen-food-llc-recalls-frozen-meat-and-poultry-sfihas-products-produced-without
WOW Frozen Food LLC Recalls Frozen Meat and Poultry Sfihas Products Produced Without Benefit of Inspection

FSIS Announcement

WASHINGTON, March 17, 2023 – WOW Frozen Food LLC, a Plantation, Fla. establishment, is recalling approximately 488 pounds of meat and poultry sfihas products that were produced without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Sunday, March 19, 2023

Pesto Pasta Sauce Recalled for Undeclared Pine Nuts

BC Gourmet USA, Inc. of Lynn, Massachusetts is recalling 906 units of Scarpetta Brand Pink Pesto, because it contains undeclared pine nut allergen.  The recall was initiated after the firm discovered that product containing tree nuts were distributed in packaging that did not reveal the presence of pine nuts. Subsequent investigation indicates the problem was caused by a document-control deviation.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bc-gourmet-usa-inc-issues-allergy-alert-undeclared-pine-nuts-scarpetta-brand-pink-pesto
BC Gourmet USA, Inc. Issues Allergy Alert on Undeclared Pine Nuts in Scarpetta Brand Pink Pesto
Summary
Company Announcement Date:  March 16, 2023
FDA Publish Date:  March 16, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Pine Nuts
Company Name:  BC Gourmet USA, Inc.
Brand Name:  Scarpetta
Product Description:  Pink pesto pasta sauce

Yogurt Parfait Bars Recalled After Co-Manufacturer Finds Listeria In Facility

Clio Snacks of Piscataway, N.J. is voluntarily recalling 581 cases of its Strawberry Granola & Greek Yogurt Parfait Bar due to potential contamination with Listeria monocytogenes.  This potential limited exposure was found at a third-party manufacturer’s facility where Parfait Bars are produced. The third-party manufacturer does not manufacture any other Clio products. Clio does not manufacture Parfait bars at its own facility.  The recall was the result of a routine testing program by the company which revealed that affected Strawberry Parfait product produced by Clio’s contract manufacturer may contain Listeria monocytogenes. The third-party manufacturer has ceased production and Clio has ceased distribution of the affected product while the FDA and the company continue their investigation into what caused the problem.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/regional-recall-clio-snacks-voluntarily-recalls-strawberry-granola-greek-yogurt-parfait-bars-select
Regional Recall: Clio Snacks Voluntarily Recalls Strawberry Granola & Greek Yogurt Parfait Bars from Select Walmart Stores Because of Possible Health Risk
Summary
Company Announcement Date:  March 14, 2023
FDA Publish Date:  March 15, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Listeria monocytogenes
Company Name:  Clio Snacks
Brand Name:  Clio
Product Description:  Strawberry Granola & Greek Yogurt Parfait Bar

Monday, March 13, 2023

Reducing Food Waste Through Thoughtful Utilization

In the Washington Post, an opinion piece discusses food waste from a position we have long taken...better utilization. From the time food is processed/prepared, it starts down a path of fading quality to the point where it is no longer edible. Depending on whether it is from a restaurant where that path is short, to retail food items where there is a longer time until it is no longer usable, food too often reaches that point where there it must be thrown out.

Certainly using it when it still has the quality we desire is best. So basically, using it well before the stated shelf-life is best. Best utilization also includes making food that will be eaten in a reasonable amount of time, or ordering only what we can eat in one setting .

But once the food quality changes, perhaps to the point where it is less than what we would want, the author opines that there are still avenues where this food can be utilized. He looks at this transition in the nature of the given food as just an opportunity to make something different that is not only edible, but perhaps desirable.
"By focusing on using food beyond the confines of our first imaginings, we’re granted access to a world of flavor — in soup that has tightened and melded overnight into a delicious sauce, or a dressing whose dregs improve a lunchtime sandwich. We also attain invaluable culinary intelligence, learning how flavor migrates from one ingredient to another, what happens to liquid and fat overnight, how acid and salt can soften what has hardened, how clever knife work can crisp what has sagged."
So okay for a chef to say, but what can we do?  Could groups like Extension, food banks, food pantries promote alternative uses?  This could be development and dissemination of  recipes that utilize items food pantries often have difficulty in moving.....or items that no longer have the same quality but still have nutrient value.  Could milk be made into kefir or yogurt?  What about brown bananas?  What can we utilize in making easy-to-make soups?

Washington Post
https://www.washingtonpost.com/opinions/2023/03/13/food-waste-problem/
We’re thinking about food ‘waste’ all wrong
By Tamar Adler
March 13, 2023 at 7:00 a.m. EDT
Tamar Adler, a former professional cook, is the author of “An Everlasting Meal: Cooking With Economy and Grace,” “Something Old, Something New: Classic Recipes Revised” and, most recently, “The Everlasting Meal Cookbook: Leftovers A-Z.”

USDA Issues Public Health Alert for Chicken with Undeclared Cashews

USDA - FSIS is issuing a public health alert due to concerns that fully cooked, ready-to-eat (RTE) chicken salad product may contain cashews a known allergen, which is not declared on the product label.  (A recall was not requested because the products are no longer available for purchase.)  The problem was discovered when the firm notified FSIS that it received a consumer complaint that cashews were found in the chicken salad product.  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/fsis-issues-public-health-alert-trader-joes-chicken-salad-due-misbranding-and
FSIS Issues Public Health Alert for Trader Joe’s Chicken Salad Due to Misbranding and an Undeclared Allergen

TAYLOR FARMS NORTHWEST LLC

FSIS Announcement

WASHINGTON, March 10, 2023 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns that fully cooked, ready-to-eat (RTE) chicken salad product may contain cashews a known allergen, which is not declared on the product label. FSIS is issuing this public health alert to ensure that consumers are aware that these products should not be consumed. A recall was not requested because the products are no longer available for purchase.

Company Expands Recall of Prescription Pet Foods with Elevated Vitamin D Levels

Nestlé Purina PetCare Company is expanding its voluntary recall of Purina Pro Plan Veterinary Diets EL Elemental (PPVD EL) prescription dry dog food due to a supplier error resulting in potentially elevated levels of vitamin D in two additional product lots, which precede the production dates of the previously recalled lots (posted on February 8, 2023).  The expansion comes following an investigation prompted by Purina that uncovered new information about a production error from a U.S. supplier that was made only to this specific formula and resulted in potentially elevated levels of vitamin D.  The Purina product is only sold through veterinarians.

Vitamin D is an essential nutrient for dogs; however, ingestion of elevated levels can lead to health issues depending on the level of vitamin D and the length of exposure. Vitamin D toxicity may include vomiting, loss of appetite, increased thirst, increased urination, and excessive drooling to renal (kidney) dysfunction.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nestle-purina-petcare-company-expands-voluntary-recall-purina-pro-plan-veterinary-diets-el-elemental
Nestlé Purina Petcare Company Expands Voluntary Recall of Purina Pro Plan Veterinary Diets El Elemental Dry Dog Food in the U.S. Due to Potentially Elevated Vitamin D
Summary
Company Announcement Date:  March 10, 2023
FDA Publish Date:  March 10, 2023
Product Type:  Animal & Veterinary
Reason for Announcement:  Potential Elevated Ingredient Level
Company Name:  Nestle Purina PetCare Company
Brand Name:  Purina
Product Description:  Pro Plan Veterinary Diets EL Elemental (PPVD EL) prescription dry dog food

Friday, March 10, 2023

Pet Food Supplement Recalled for Elevated Levels of Vitamin A

Stratford Care USA, Inc of Odessa, Florida is recalling multiple brands of Omega-3 Supplements for cats and dogs due to potentially elevated levels of Vitamin A. Vitamin A is an essential nutrient for dogs; however, ingestion of elevated levels can lead to health issues depending on the level of Vitamin A and the length of exposure. Vitamin A toxicity may include general malaise, anorexia, nausea, peeling skin, weakness, tremors, convulsions, paralysis, and death.  Stratford Care USA, Inc is taking this action after receiving a single Serious Adverse Event from a sole consumer regarding their dogs’ exhibiting signs of Vitamin A toxicity after consuming the supplement. This is the only Adverse Event to date. Currently Stratford Care USA, Inc is taking all necessary steps in collaboration with the FDA to remove all products with these lot numbers from the market.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/stratford-care-usa-inc-recalls-omega-3-supplements-cats-and-dogs-because-possible-elevated-levels
Stratford Care USA, Inc Recalls Omega-3 Supplements for Cats and Dogs Because of Possible Elevated Levels of Vitamin A
Summary
Company Announcement Date:  March 09, 2023
FDA Publish Date:  March 10, 2023
Product Type:  Animal & Veterinary
Reason for Announcement:  Potential elevated levels of Vitamin A
Company Name:  Stratford Care USA, Inc
Brand Name:  Multiple brands
Product Description:  Omega-3 Supplements for cats and dogs

NJ Importer Recalls 100K Lbs of Goat Meat Due to No USDA Mark of Inspection

Dahlia Imports, LLC, a Newark, N.J. firm, is recalling approximately 96,624 pounds of raw bone-in goat products imported into the United States from Australia that were not presented for import reinspection and thus had no USDA mark of inspection.  The problem was discovered during routine FSIS surveillance activities of imported products at retail stores.

https://www.fsis.usda.gov/recalls-alerts/dahlia-imports-llc-recalls-raw-bone-goat-products-imported-without-benefit-import
Dahlia Imports, LLC Recalls Raw Bone-in Goat Products Imported Without Benefit of Import Reinspection

FSIS Announcement

WASHINGTON, March 6, 2023 – Dahlia Imports, LLC, a Newark, N.J. firm, is recalling approximately 96,624 pounds of raw bone-in goat products imported into the United States from Australia that were not presented for import reinspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today..