Label reads in part "***Full Tilt Ice Cream Fudge Brownie Swirl Vegan***one…
Full Tilt Ice Cream recalled this product and the FDA reported the enforcement action on 24 May 2017 as Class II. The recall was initiated by the firm. Full Tilt Ice Cream is recalling pint size ice cream due to undeclared allergen, wheat. Flour is listed in the ingredient statement, however wheat is not declared.
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
Product
Label reads in part "***Full Tilt Ice Cream Fudge Brownie Swirl Vegan***one pint***Ingredients: Coconut Milk (coconut milk, water, citric acid), organic evaporated cane juice, bownie bits (flour, sugar, cocoa powder, non-aluminum baking powder, salt, vanilla extract, coconut oil.), fudge (cocoa powder, unsweetened chocolate, sugar, cocoa fat, soy lecithin), vanilla extract guar gum***" Please note bownie is how this word appears on the label. UPC 6 96859 21161 4 The product is packed in paper pint containers with paper and plastic lid. Product is shrink wrapped six per flat (not in a cardboard case) and not packed in a master carton. Distributed as shrink wrapped, six pints per flat.
UPC
696859211614
Reason for recall
Full Tilt Ice Cream is recalling pint size ice cream due to undeclared allergen, wheat. Flour is listed in the ingredient statement, however wheat is not declared.
Five things about this record are not in the record itself, and each one changes how it should be read.
Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
This record is the only one the FDA opened for its recall event, so it covers a single product code.
The recall ran for 3 months, from 25 April 2017 to termination on 19 July 2017. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
The FDA published the enforcement report 4 weeks after the firm began the recall.
Recalls of ice cream or frozen dessert run a median of 7 months, so this one was shorter than usual for its category. Ice cream and frozen desserts are ready to eat and never cooked again, and freezing preserves Listeria rather than killing it, which is why a positive environmental sample in a frozen dessert plant becomes a recall rather than a corrective action.
An undeclared allergen recall means a food contained one of the major allergens and the label did not say so, either because the wrong label was applied or because an ingredient carried an allergen nobody traced.
A preventive controls plan covers an undeclared allergen under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
21 CFR 117.135(c)(2)
Food allergen controls: the written preventive controls that keep an allergen out of a food it does not belong in, and that get the allergens present onto the label.
21 CFR 101.4
Ingredient declaration: every ingredient listed by its common name, in descending order of predominance, on the label of a packaged food.
21 CFR 117 subpart G
Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
Other ice cream and frozen desserts recalls for the same reason
These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Full Tilt Brand ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. These products contain ice cream mix, an ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc.
Full Tilt Brand ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. These products contain ice cream mix, an ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc.
Full Tilt Brand ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. These products contain ice cream mix, an ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc.
Full Tilt Brand ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. These products contain ice cream mix, an ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc.
Full Tilt Brand ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. These products contain ice cream mix, an ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc.
Full Tilt Brand ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. These products contain ice cream mix, an ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc.
Full Tilt Brand ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. These products contain ice cream mix, an ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc.
Full Tilt Brand ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. These products contain ice cream mix, an ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc.
Full Tilt Brand ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. These products contain ice cream mix, an ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc.
Full Tilt Brand ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. These products contain ice cream mix, an ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc.
21 CFR 117.135(c)(2) is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.
