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