Tropical Dreams Super Premium Ice Cream Vegan Chocolate ; Pint container; UPC…
Edney and Sellers, Ltd. recalled this product and the FDA reported the enforcement action on 14 November 2018 as Class II. The recall was initiated by the firm. During FDA inspection it was found that soy oil was not declared on package label
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
- Tropical Dreams Super Premium Ice Cream Vegan Chocolate ; Pint container; UPC 685450676526 Ingredients: Coconut milk, organic sugar, water, cocoa powder, malt syrup. . Food Allergy warning: This product was prepared at facilities where milk, eggs, wheat, peanuts, tree nuts and chocolate were processed.
- UPC
- 685450676526
- Reason for recall
- During FDA inspection it was found that soy oil was not declared on package label
- Recalling firm
- Edney and Sellers, Ltd.
- Firm location
- Kamuela, Hawaii, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0368-2019
- Quantity
- 23 cases - 8 pints per case
- Distribution
- HI only
- Initiated
- 19 October 2018
- Reported by FDA
- 14 November 2018
- Terminated
- 17 December 2018
- Firm notified by
- Letter
- Product codes
- All lot numbers up to 625305
Reading this record
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 is one of 4 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 4 separate recalls, which almost every published figure does, overstates it by a factor of 4. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 4 of them.
- The recall ran for 8 weeks, from 19 October 2018 to termination on 17 December 2018. 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.
What this recall was for
Undeclared allergens
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.
The allergens named in this record: soy.
Filed under ice cream and frozen desserts, milk and dairy, nuts and seeds, snacks and confectionery, sauces, dips and condiments, beverages and juice and eggs. A product can sit in more than one.
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.
Other records from Edney and Sellers, Ltd.
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
All 5 records for Edney and Sellers, Ltd.
All 2018 recalls · All FDA food recall data
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.
Early accessRecall 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.