20 Mile Coconut, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers.
Barron County Organics recalled this product and the FDA reported the enforcement action on 24 February 2021 as Class II. The recall was initiated by the firm. Ingredients were not pasteurized after blending as required by State of Wisconsin.
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
20 Mile Coconut, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48810. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813.
UPC
5000548810
Reason for recall
Ingredients were not pasteurized after blending as required by State of Wisconsin.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes
Batch #: 00072120-001, 00091420-001.
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 17 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 17 separate recalls, which almost every published figure does, overstates it by a factor of 17. 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 17 of them.
The recall ran for 4 months, from 3 February 2021 to termination on 9 June 2021. 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 2 states, and the FDA published the enforcement report 3 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.
Named in the distribution pattern: Minnesota, Wisconsin. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.
A process deviation recall means the process ran outside its validated limits: a thermal process that did not reach its time and temperature, a pH that drifted, or a seal that failed.
A preventive controls plan covers a process deviation 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 113
Thermally processed low-acid foods in hermetically sealed containers: the scheduled process, its establishment by a competent authority, and the records proving every container received it.
21 CFR 114
Acidified foods: the controls on equilibrium pH at or below 4.6, and the process that achieves it.
21 CFR 117.150
Corrective actions: what a facility does when a preventive control was not properly implemented, including identifying and correcting the problem and evaluating the food for safety.
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 113 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.
