Fist Listeria recall and one FDA Warning Letter and one Salmonella recall.

Velvet Ice Cream has announced it is voluntarily recalling all of its ice cream and sherbet products made on or after March 24, 2021 as a precaution because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

No illness or injury has been associated with the recalled products, which are being recalled in cooperation with the U.S. Food and Drug Administration. The issue was identified as a result of the company’s routine testing.

The products were distributed to Indiana, Kentucky, Ohio, and West Virginia through various drug stores, convenience stores and supermarkets. They are packaged in various sizes and containers.

The products were distributed and sold in supermarkets from on or after March 24, 2021 with the following product codes, which can be found at the bottom or side of the container:

Product Code Item Description
21104 Buehler’s Chocolate Pail
21104 Buehler’s Neapolitan Pail
21104 Buehler’s Vanilla Pail
21089 Discount Drug Mart Chocolate Swirl Pail
21106 Discount Drug Mart Neapolitan 56oz
21095 Discount Drug Mart Strawberry 56
21091 Discount Drug Mart Vanilla 56
21083 Discount Drug Mart Vanilla Pail
21096 North Star Frog Spit
21097 North Star Frog Spit
21098 North Star Frog Spit
21099 North Star Frog Spit
21089 Whale of a Pail Chocolate Fudge Pai
21090 Whale of a Pail Cookies n Cream
21104 Whale of a Pail Neapolitan
21103 Ruggle’s Orange Sherbet Quarts
21104 Whale of a Pail Vanilla Chocolate
21089 Whale of a Pail Vanilla
Product Code Item Description
21090 Whale of a Pail Vanilla
21090 Super Dip Chocolate Pail
21103 Super Dip Chocolate Swirl Pail
21083 Super Dip Chocolate Swirl Pail
21089 Super Dip Chocolate Swirl Pail
21083 Super Dip Cookie n Cream Pail
21106 Super Dip Neapolitan 56oz
21104 Super Dip Neapolitan Pail
21095 Super Dip Strawberry 56
21106 Super Dip Superfriends 56oz
21091 Super Dip Vanilla 56
21083 Super Dip Vanilla Pail
21103 Super Dip Vanilla Pail
21089 Super Dip Vanilla Pail
21090 Super Dip Vanilla Pail
21106 Super Dip Vanilla/Orange 56oz
21106 Velvet erVanilla Lovers Trio 56oz
21091 Velvet Banana Cream Pie 56
21088 Velvet Birthday Cake 3 gallon
21084 Velvet Black Walnut 3 gallon
21099 Velvet Blackberry Cobbler 56
21095 Velvet Blueberry Cheesecake 56
21095 Velvet Buckeye Brownie 56
21091 Velvet Buckeye Brownie 56
21095 Velvet Buckeye Classic 56
21096 Velvet Buckeye Classic Pint
21102 Velvet Buckeye Sandwich 12/10pk
21096 Velvet Butter Pecan & Cashew Pint
21105 Velvet Campfire Smores 56oz
21100 Velvet Caramel Pecan 56
21106 Velvet Chocolate Pint
21096 Velvet Chocolate Pint
21105 Velvet Cookie Dough Extreme 56oz
21105 Velvet Cookie Dough Extreme 3 gallon
21084 Velvet Cookie n Cream 3 gallon
21092 Velvet Cookies n Cream Pint
21103 Velvet Cotton Candy 3 gallon
21092 Velvet Dutch Chocolate 56
21089 Velvet Dutch Chocolate 3 gallon
21102 Velvet Dutch Chocolate 3 gallon
21099 Velvet Elephant Ear 56
21084 Velvet Elephant Ear 3 gallon
Product Code Item Description
21092 Velvet Homemade Vanilla 56
21105 Velvet Homemade Vanilla 56oz
21100 Velvet Kentucky Praline Pecan 56
21085 Velvet Lime Sherbet Quart
21103 Velvet Lime Sherbet Quarts
21091 Velvet Mint Chocolate Chip 56
21102 Velvet Mint Chocolate Chip 3 gallon
21091 Velvet Moose Tracks 56
21095 Velvet Moose Tracks 56
21096 Velvet Moose Tracks Pint
21092 Velvet Olde Tyme Vanilla 56
21105 Velvet Olde Tyme Vanilla 56oz
21102 Velvet Olde Tyme Vanilla 3 gallon
21084 Velvet Orange Sherbet 3 gallon
21085 Velvet Orange Sherbet Quart
21103 Velvet Orange Sherbet Quarts
21091 Velvet Original Vanilla 56
21084 Velvet Original Vanilla 3 gallon
21089 Velvet Original Vanilla 3 gallon
21100 Velvet Original Vanilla 3 gallon
21102 Velvet Original Vanilla 3 gallon
21084 Velvet Pineapple Sherbet 3 gallon
21084 Velvet Pineapple Sherbet Quart
21085 Velvet Pineapple Sherbet Quart
21103 Velvet Pineapple Sherbet Quarts
21103 Velvet Rainbow Sherbet 3 gallon
21103 Velvet Rainbow Sherbet Quarts
21085 Velvet Raspberry Sherbet Quart
21084 Velvet Sea Salt Caramel Toffee 3 gallon
21099 Velvet Summertime Peach 56
21099 Velvet Summertime Peach 3 gallon
21084 Velvet Summertime Peach 3 gallon
21092 Velvet Triple Chocolate Chunk 56
21100 Velvet Vanilla Bean 3 gallon
21088 Velvet Vanilla Pint
21106 Velvet Vanilla Pint

In 2019, Velvet Ice Cream Company Inc.’s ice cream manufacturing facility in Utica, OH, was inspected by the FDA from Jan. 23 to Feb. 14 and the results were not good. Lab tests showed the plant was harboring the pathogen Listeria monocytogenes.

Environmental samples collected at the facility during this year’s inspection returned positive results for the same strain of the potentially deadly pathogen inspectors found during an FDA inspection in 2018.

“During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation,” FDA’s East Division Director said in a warning letter to the ice cream manufacturer.

Based on the FDA’s inspectional findings, and the analytical results for the environmental samples, the FDA determined that the ice cream manufactured in the firm’s facility is adulterated, in that it was prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health.

The following were among Velvet Ice Cream Company Inc.’s violations of the regulations for Hazard Analysis and Risk-Based Preventive Controls:

  • Firm’s are required to identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented, and the food manufactured, processed, packed, or held by their facility will not be adulterated or misbranded; “In your food safety plan, you identified environmental pathogens as a hazard requiring preventive controls and identified sanitation controls to address the hazard. However, as evidenced by environmental findings that indicate a resident strain of L. monocytogenes in your facility, you did not implement sanitation controls adequate to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen L. monocytogenes.”
  • Nine environmental swabs collected by FDA during the most recent inspection were positive for L. monocytogenes; “Furthermore, environmental swabs collected during our 2018 inspection revealed L. monocytogenes in nine swabs within your facility and environmental swabs collected during our 2017 inspection revealed L. monocytogenesin three swabs within your facility.”
  • Whole genome sequencing (WGS) of isolates detected in the FDA environmental samples identified twenty-one isolates representing six different strains of L. monocytogenes. The same strain of L. monocytogenes was identified in seven isolates from environmental samples collected during the 2019 inspection and eight isolates collected during the 2018 inspection.
  • The FDA advised the firm of those WGS results via a conference call on February 27, 2019, and the presence of the same strain of L. monocytogenes over multiple years indicates that there has been a resident pathogen or harborage site in their facility since 2018.
  • Additionally, “that strain of L. monocytogenes was genetically identical to one clinical isolate collected in 2018, which indicates this strain has the capability of causing human illness.”

These findings demonstrate that the firm’s sanitation procedures have been inadequate to significantly minimize or prevent L. monocytogenes in their facility. Once L. monocytogenes is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product; “It is essential to identify the areas of the food processing plant where this organism is able to survive and grow to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.”

The FDA acknowledged that the firm has committed to performing corrective actions in written responses which we received by the FDA on February 7, February 27, March 16, and April 24, 2019; “In your written responses, you indicate that you have conducted a root cause analysis to identify the source of our findings, cleaned and sanitized your production environment, conducted environmental swabbing to verify the effectiveness of your cleaning, and completed other activities to address the problems.” The FDA noted that the firm’s effectiveness of their corrective actions will be “verified” during the FDA’s next inspection.

The FDA also noted the following cGMP violations:

  • The firm did not clean their non-food contact surfaces in a manner, and as frequently as necessary, to protect against contamination; “Specifically, on January 30, 2019, our investigators observed an employee using a high-pressure hose to spray the floor with water while performing sanitation operations. They observed overspray from the floor onto equipment reported as having been cleaned and from the floor onto unopened buckets of ingredients that were going to be used to produce ice cream the next day.”
  • The firm’s corrective action indicates that they will lower the water pressure and retrain their employees on the use of water and clean up procedures; “We will verify the adequacy of this corrective action during our next inspection.”
  • The plant was not constructed and designed to facilitate maintenance and sanitary operations; “Specifically, the design of the production floor does not allow for the proper drainage of water. Water used in the cleaning of equipment pools in various locations throughout the production area of your facility, which can provide harborage areas for pathogenic bacteria such as Listeria.”

The firm’s corrective actions indicate that they have re-sloped their floor to address the observations of pooling water. The FDA noted that they will verify the adequacy of this corrective action during their next inspection.

FDA investigators added that the above is not intended to be an “all-inclusive list of violations” at the firm’s facility or in connection with their RTE ice cream products, and that the firm is responsible for ensuring that their facility operates in compliance with the Act, the CGMP & PC rule, and other applicable laws.

“You should take prompt action to correct the violations noted in this letter,” the FDA advised, “Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.”

In 2012, Velvet Ice Cream was notified that peanut products sold to their company from Sunland, Inc., which were used to make select peanut butter-flavored ice creams, may be contaminated with Salmonella. Thus, the Ohio-based ice cream manufacturer is voluntarily recalling products that may contain contaminated nut products. The recalled products are only sold at convenience stores, small, independent retailers and ice cream parlors in Ohio, Indiana, Kentucky, Tennessee, Virginia and West Virginia.

Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (ie:, infected aneurysms), endocarditis and arthritis.

The following products with specific code numbers are covered under the recall:

Code Numer* Manufactured Date
Velvet Supreme Peanut Butter Cup – 1/2 gallon UPC #70682-10119 10181 6/30/2010
Velvet Peanut Butter Cup – 3 gallon UPC #70682-10539 10181 6/30/2010
Velvet Buckeye Classic – 56oz UPC #70682-10038 10193 7/12/2010
Velvet Buckeye Classic – 3 gallon UPC #70682-10519 10193 7/12/2010
Velvet Buckeye Classic – 3 gallon UPC #70682-10519 12207 7/25/2012
Velvet Buckeye Classic – 3 gallon UPC #70682-10519 12227 8/14/2012
Velvet Buckeye Classic – pints UPC #70682-10423 12251 9/07/2012

*Found on the bottom of 56oz and pint cartons, label of 3 gallon container and flap of half-gallon carton

Product descriptions:

  • Buckeye Classic ice cream (Creamy peanut butter ice cream swirled with thick chocolate fudge and chocolate-covered peanut butter candies) 56oz carton, 3 gallon containers and pints
  • Chocolate Peanut Butter Cup ice cream (Chocolate ice cream with peanut butter swirls) half-gallon cartons and 3 gallon containers