Helados La Tapatia ; Cookies 'n' Cream Biscuits au Chocolat; Net Wt. 4 oz, (113g) UPC 6…
Helados La Tapatia, Inc. recalled this product and the FDA reported the enforcement action on 6 January 2016 as Class I. The recall was initiated by the firm. Product has undeclared allergens: soy and wheat. .
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
Helados La Tapatia ; Cookies 'n' Cream Biscuits au Chocolat; Net Wt. 4 oz, (113g) UPC 6 34242 60007 2; INGREDIENTS FOR ICE FRUIT BARS: ICE CREAM MIX (CREAM, MILK, FRESH CONDENSED SKIM MILK, SUCROSE, CORN SYRUP. DESSERT SOLIDS (WHEY, REDUCED LACTOSE, WHEY AND NON FAT DRIED MILK) AND STABILIZER (GUAR GUM, MONO, AND DIGLYCERIDESJ, CALCIUM SORBATE, POLYSORBATE 40, CELLULOSE GUM AND CARRAGENAN),WATER, CHOCOLATE COOKIES AND SUGAR. MAY CONTAIN ALMONDS, PEANUTS, CASHEWS,HAZELNUTS, PECANS AND/OR WALNUTS. Mfg by: Helados La Tapatia, Inc. Fresno, CA 93772 Plant # 06-02536F
UPC
634242600072
Reason for recall
Product has undeclared allergens: soy and wheat. .
UPC 6 34242 60007 2; lot number ¿286 15 15¿ lot number ¿286 15 16¿ .
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
Class I means the FDA judged a reasonable probability that the product would cause serious health consequences or death. 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 13 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 13 separate recalls, which almost every published figure does, overstates it by a factor of 13. 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 13 of them.
The recall ran for 15 months, from 27 October 2015 to termination on 8 February 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 distribution pattern names 4 states, and the FDA published the enforcement report 2 months after the firm began the recall.
Recalls of ice cream or frozen dessert run a median of 7 months, so this one was longer 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.
Named in the distribution pattern: California, Nevada, Washington, Arizona. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.
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.
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.
