Valentine Candy Recalled for Undeclared Tree Nuts

Silvestri Sweets Inc. of Geneva, IL is voluntarily recalling its 8 ounce bags of Favorite Day branded Valentine’s Milk Chocolate Covered Caramels with Nonpareils because they may contain an undeclared tree nut.   The recall was initiated after it was discovered that possible tree nut inclusions were distributed in packaging and/or product that did not reveal the presence of tree nuts. Subsequent investigation indicates the problem may have been caused by a temporary breakdown in the company’s production and packaging process.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/silvestri-sweets-issues-voluntary-allergy-alert-undeclared-pecan-milk-chocolate-caramels
Silvestri Sweets Issues Voluntary Allergy Alert on Undeclared Pecan in Milk Chocolate Caramels
Summary
Company Announcement Date: February 14, 2023
FDA Publish Date:  February 16, 2023
Product Type:  Food & Beverages  Snack Food Item  
Reason for Announcement:  Undeclared pecan allergen
Company Name:  Silvestri Sweets Inc.
Brand Name:  Favorite Day
Product Description:  Milk Chocolate Covered Caramels with Nonpareils

Asian Spice Mix Recalled for Undeclared Sesame After Mislabeling Incident

Wismettac Asian Foods, Inc., Santa Fe Springs, CA is recalling 10.58 oz packages of Shirakiku brand Spice Seasoning products (Spice Ichimi Togarashi 300g and Spice Shichimi Togarashi 300g). The product package of Ichimi spice seasoning contains Shichimi spice seasoning contents (incorrect package) causing the undeclared allergen of sesame seeds. The outer carton of “Ichimi” and “Shichimi” may possibly contains inner packages of “Ichimi”, and the inner packages contain “Shichimi” contents. The recall was initiated after it was discovered that the product containing sesame was distributed in packaging that did not reveal the presence of sesame. Subsequent investigation indicates the problem was caused by a human error during the packing process.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wismettac-asian-foods-issues-allergy-alert-undeclared-spice-seasoning
Wismettac Asian Foods Issues Allergy Alert on Undeclared Spice Seasoning
Summary
Company Announcement Date:  February 14, 2023
FDA Publish Date:  February 14, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared sesame
Company Name:  Wismettac Asian Foods, Inc.
Brand Name:  Shirakiku
Product Description:  Ichimi spice powder, 10.58 oz

CA Distributor Pulls More Imported Snack Products for Lack of Allergen Labeling

Daiso California LLC of La Mirada, CA is recalling even more snack products that lack proper allergen labeling.  This company has issued other recalls over the past few months for the same issue....lack of allergen labeling on imported snack products.  The last posted recall was issue on February 3, 2023.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/daiso-issues-allergy-alert-prepackaged-snacks-0
Daiso Issues Allergy Alert for Prepackaged Snacks
Summary
Company Announcement Date: February 13, 2023
FDA Publish Date:  February 13, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk, wheat, soy, tree nuts
Company Name:  Daiso California, LLC
Brand Name:  Various
Product Description:   Various Snack Foods

Health Alert issued for A CA Establishment's Sausage Product Due to Undeclared Allergens

USDA is issuing a public health alert due to concerns that the ready-to-eat (RTE) pork sausage link products made by GOULART'S SAUSAGE CO of San Jose CA.  The product may contain milk, a known allergen, which is not declared on the finished product label.  The problem was discovered during routine inspection activities when FSIS observed the establishment adding nonfat dry milk to an ingredient in the Linguica links products. The finished product labels for these Linguica links products do not identify nonfat dry milk as an ingredient and do not declare milk as an allergen.


https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-ready-eat-pork-sausage-products-due-misbranding-and
FSIS Issues Public Health Alert for Ready-To-Eat Pork Sausage Products Due to Misbranding and an Undeclared Allergen

GOULART'S SAUSAGE CO.

WASHINGTON, Feb. 8, 2023 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns that the ready-to-eat (RTE) pork sausage link products may contain milk, a known allergen, which is not declared on the finished product label. FSIS is issuing this public health alert to ensure that consumers with an allergy to dairy are aware that these products should not be consumed. A recall was not requested because the products are no longer available for purchase.

Prescription Pet Food Recalled for Elevated Levels of Vitamin D

Nestlé Purina PetCare Company is voluntarily recalling select lots of Purina Pro Plan Veterinary Diets EL Elemental (PPVD EL) prescription dry dog food due to potentially elevated levels of vitamin D.  Ingestion of elevated levels can lead to health issues, depending on the level of vitamin D and the length of exposure, can include vomiting, loss of appetite, increased thirst, increased urination, and excessive drooling to renal (kidney) dysfunction.  Purina is taking this action after receiving two contacts about two separate confirmed cases of a dog exhibiting signs of vitamin D toxicity after consuming the diet, to date. Once taken off the diet, each of these dogs recovered.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nestle-purina-petcare-company-voluntarily-recalls-purina-pro-plan-veterinary-diets-el-elemental-dry
Nestlé Purina Petcare Company Voluntarily Recalls Purina Pro Plan Veterinary Diets El Elemental Dry Dog Food in the U.S. Due to Potentially Elevated Vitamin D
Summary
Company Announcement Date:  February 08, 2023
FDA Publish Date:  February 08, 2023
Product Type:  Animal & Veterinary  Food & Beverages 
Reason for Announcement:  Potentially elevated Vitamin D
Company Name:  Nestle Purina PetCare Company
Brand Name:  Purina
Product Description:  Veterinary Diets EL Elemental Dry Dog Food

OR Company Recalls Snack Products for Incorrect Allergen Labeling

Pilgrim’s Roasted Nut’Z of North Plains, Oregon is recalling following products due to undeclared milk, soy, and/or walnut.   The products are packaged in either 8 oz plastic cone bags or 8 oz pouch bags with no lot code or best by date. The products were sold in retail stores in Oregon, Washington and California and through the company’s website (https://pilgrimsroastednutz.com/External Link Disclaimer) and farmers markets and events in Oregon.

Looks like someone didn't read any of the regulations, but guessed what was to go on the label.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pilgrims-roasted-nutz-issues-allergy-alert-undeclared-milk-soy-walnut-snack-products
Pilgrim’s Roasted Nut’z Issues Allergy Alert on Undeclared Milk, Soy, Walnut in Snack Products
Summary
Company Announcement Date:  February 06, 2023
FDA Publish Date:  February 08, 2023
Product Type:  Food & Beverages  Nuts & Nut Products
Reason for Announcement:  Undeclared milk, soy, walnut
Company Name:  Pilgrim’s Roasted Nut’ Z
Brand Name:  Pilgrim’s Roasted Nut’ Z
Product Description:  Chocolate Toffee Almonds, Crème Brulee Cashews, Tri-Color Chocolate Expresso Bean, more

Imported Cake Product Recalled for Undeclared Eggs

Titans Global Inc. of City of Industry, CA, is recalling its 95g packages of “JSJ Chocolate Cake", “JSJ ZSR Cake”, “JSJ DMC Leaf Cake” food treats because they may contain undeclared eggs.  Product is imported.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/titans-global-inc-issues-allergy-alert-undeclared-egg-jsj-chocolate-cake-jsj-zsr-cake-jsj-dmc-leaf
Titans Global Inc Issues Allergy Alert on Undeclared Egg in “JSJ Chocolate Cake”, “JSJ Zsr Cake”, “JSJ DMC Leaf Cake”
Summary
Company Announcement Date:  February 06, 2023
FDA Publish Date:  February 06, 2023
Product Type:  Food & Beverages
Reason for Announcement:  undeclared egg
Company Name:  Titans Global Inc
Brand Name:  JSJ
Product Description:  Cake

Warning Letter Issued for Salmonella Outbreak Linked to Peanut Butter - A Case Study for Testing for Safety in Light of Resident Contamination

FDA issued a Warning Letter to Smucker after conducting an inspection in their Lexington, KY facility after product from that facility was linked to a Salmonella outbreak.40505-3728 from May 19, 2022, through June 9, 2022.  The recall was published on May 21, 2022.  CDC reports that 21 people from 17 states fell ill from the product.

Inspectors found "found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation" and "failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule"

I tried to summarize this in a way to better focus on the issues.  One primary point is that if there is a issue, using testing to resolve did not work.

• Through WGS (whole genome sequencing, "FDA identified five recent 2022 clinical isolates (samples collected from ill people) which matched over one hundred third-party peanut butter and environmental isolates from Kentucky collected from 2014 to 2017."  "The presence of the same S. Senftenberg strain in [the] facility since 2010, which matched the clinical cluster, is indicative of a resident strain. "
• The company's "finished product testing records from January 1, 2021, to February 23, 2022, indicate that [the company] detected Salmonella in .... RTE peanut butter on numerous occasions, i.e., October 22 and December 15, 2021; and February 4, 9, 10, 20, and 21, 2022, and that [the company's] corrective actions were not sufficient to address the root cause of the contamination.

• The issue - 'the establishment identified a leak in the air intake vent of the cooling chamber of Roaster as a source of water entering the equipment and that was repaired, however within a few days  after the repair was completed, Salmonella was detected.  Subsequently, additional samples were tested  from the lot[s] produced immediately prior to and after the product that tested positive.  testing found that that initially, lots tested negative for Salmonella but then identified two additional positive lots. The next day, Salmonella was detected  in a lot. Similar to February 20, after testing  lots that initially tested negative for Salmonella, additional lots tested positive.'

• The company indicated that when the additional samples test negative, they destroy all  production lots to provide further assurance we have bracketed and eliminated any potential contamination.” "However, the positive test results for lots for which Salmonella was previously not detected show the limitations of reliance on [the]testing program to identify contamination as a way to prevent contaminated products from reaching consumers. Further, the S. Senftenberg outbreak shows that neither [the company's] corrective actions nor finished product testing was adequate to prevent contaminated product from reaching consumers and causing illnesses."
• The company responded on July 1, 2022 that they  updated the finished product testing procedures to include a “Hold” procedure in the event a single positive result that is detected in RTE peanut butter where lots will be held ” produced (b)(4) hours before and (b)(4) hours after the affected (i.e., positive) lot and performing further testing using (b)(4) samples from only the (b)(4) lots on “each extreme of the bracketed window” (i.e., only the (b)(4) or (b)(4) lot on either end of the held product).   The concern from FDA's letter is that this approach in response to a contamination event would not ensure all affected product would be identified and prevented from entering commerce. [FDA] is not aware of any data or scientific rationale to support how your (b)(4) Hold would be an effective approach to identify all product affected by a contamination event in your continuous production of RTE peanut butter. 

So basically, you cannot test your way to safety.  Salmonella should not be in that product period.  And if product is positive, testing to determine what is safe is a gamble and there are bigger issues that have to be solved.   In this case, tearing it all down and figuring out how it got there and then correcting the problem is the preventive approach.

Another interesting item was that the company did not identify Salmonella as a hazard in the post-process enviroment.  From the report, the company " did not consider the hazard of recontamination with environmental pathogens, such as Salmonella spp., at post-roasting processing steps from blanching to sorting and milling (including (b)(4)). In-process RTE peanuts are exposed to the environment at these steps, and the food does not receive further treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen."

There was a knock on the corrective action procedures in that Salmonella contamination was still being found -  The " environmental monitoring records from 2021 revealed five Salmonella positive environmental swabs in your facility on July 6, July 8, July 12, September 3, and November 16, 2021. These Salmonella positive swabs were found on the floors near your blanch nut tank rooms, roaster booth (b)(4), the stairs at the top level of the nut house (b)(4), and the stairs leading to platform “(b)(4)”. The detection of Salmonella in your facility in 5 locations in 2021, many of which were similar to locations where you detected Salmonella in 2018 and 2019, show that your corrective action procedures in response to environmental contamination in 2018 and 2019 were not sufficient to reduce the likelihood that environmental contamination would recur, as required by 21 CFR 117.150(a)(2)(ii)."

FDA finishes the report stating the concern that Salmonella may be a resident contaminate within the facility and that broader measures are needed.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jm-smucker-llc-638042-01242023

J.M. Smucker LLC
MARCS-CMS 638042 — JANUARY 24, 2023

Cereal Producer Pleads Guilty in 2018 Salmonella Outbreak for Failing to Correct Contamination Issue

 From an article in Food Safety News, the producer of Honey Smacks cereal, Kerry Inc, pleaded guilty to operating a food facility in unsanitary conditions that lead to product becoming contaminated with Salmonella.  The plea agreement will include a $19.2 million payout.

In this outbreak, at least 135 people reported being ill with 34 people hospitalized.

"Documents unsealed today revealed that Salmonella had been found on an ongoing basis at the Kerry manufacturing plant in Gridley, IL. During the time period June 2016 to June 2018, routine environmental tests detected Salmonella in the plant 81 times, including at least one positive Salmonella sample each month.  According to the plea agreement with the company, employees at the Gridley facility routinely failed to implement corrective and preventative actions to address positive Salmonella tests."

"In a related case, Ravi K. Chermala, Kerry’s Director of Quality Assurance until September 2018, previously pleaded guilty to three federal misdemeanor counts of causing the introduction of adulterated food into interstate commerce. Chermala oversaw the sanitation programs at various Kerry manufacturing plants, including the Gridley facility.  “In pleading guilty, Chermala admitted that between June 2016 and June 2018, he directed subordinates not to report certain information to Kellogg’s about conditions at the Gridley facility,” according to the Justice Department.  “In addition, Chermala admitted that he directed subordinates at the Gridley facility to alter the plant’s program for monitoring for the presence of pathogens in the plant, limiting the facility’s ability to accurately detect insanitary conditions. Chermala is scheduled to be sentenced on Feb. 16.”"

Source - https://www.foodsafetynews.com/2023/02/largest-food-safety-settlement-entered-in-federal-case-against-honey-smacks/