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
- 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