Class IITerminated · reported 2017-09-27

Kilby Cream Ice Cream Various Flavors: , Sweet Cream Size: 2.5 Gal , 7 oz.

Kilby Cream recalled this product and the FDA reported the enforcement action on 27 September 2017 as Class II. The recall was initiated by the firm. According to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage.

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
Kilby Cream Ice Cream Various Flavors: , Sweet Cream Size: 2.5 Gal , 7 oz.
Reason for recall
According to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage.
Recalling firm
Kilby Cream
Firm location
Colora, Maryland, United States
Classification
Class II
Status
Terminated
Recall number
F-3551-2017
Quantity
1 unit
Distribution
Product was distributed in MD, PA, and DE . There are 14 direct accounts affected.
Initiated
4 August 2017
Reported by FDA
27 September 2017
Terminated
3 January 2018
Firm notified by
E-Mail
Product codes
P1717, P1722

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 35 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 35 separate recalls, which almost every published figure does, overstates it by a factor of 35. 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 35 of them.
  • The recall ran for 5 months, from 4 August 2017 to termination on 3 January 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 distribution pattern names 1 state, and the FDA published the enforcement report 8 weeks after the firm began the recall.
  • Recalls of ice cream or frozen dessert run a median of 7 months, so this one was about typical 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

Process deviation

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.

Filed under ice cream and frozen desserts and milk and dairy. 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.

ReportedProductFirmReasonClass
2021-02-2420 Mile Rhubarb, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48811. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813.Barron County OrganicsIngredients were not pasteurized after blending as required by State of Wisconsin.Class II
2021-02-2420 Mile Salted Chocolate Caramel Crunch, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48801. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813.Barron County OrganicsIngredients were not pasteurized after blending as required by State of Wisconsin.Class II
2021-02-2420 Mile Maple Cream, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48806. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813.Barron County OrganicsIngredients were not pasteurized after blending as required by State of Wisconsin.Class II
2021-02-2420 Mile Peach Cream, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813.Barron County OrganicsIngredients were not pasteurized after blending as required by State of Wisconsin.Class II
2021-02-2420 Mile Black Cherry Organic Frozen Custard, Contents: One U.S. Pint, and 86 oz. Scoopers. UPC 50005-48807. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813.Barron County OrganicsIngredients were not pasteurized after blending as required by State of Wisconsin.Class II
2021-02-2420 Mile Dark Chocolate, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48805. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813.Barron County OrganicsIngredients were not pasteurized after blending as required by State of Wisconsin.Class II
2021-02-2420 Mile Chocolate Chip Cookie Dough, Organic Frozen Custard, Contents: One U.S. Pint, and 86 oz. Scoopers. UPC 50005-48803. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813.Barron County OrganicsIngredients were not pasteurized after blending as required by State of Wisconsin.Class II
2021-02-2420 Mile Mint Chocolate Chip, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813.Barron County OrganicsIngredients were not pasteurized after blending as required by State of Wisconsin.Class II

Other records from Kilby Cream

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 34 other records name this firm.

ReportedProductFirmReasonClass
2017-09-27Kilby Cream Ice Cream Various Flavors: Strawberry Cheesecake Size: 2.5 Gal , 7 oz.Kilby CreamAccording to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage.Class II
2017-09-27Kilby Cream Ice Cream Various Flavors: , Vanilla Size: 2.5 Gal , 7 oz.Kilby CreamAccording to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage.Class II
2017-09-27Kilby Cream Ice Cream, Crow Vineyard Rose Size: 2.5 GalKilby CreamAccording to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage.Class II
2017-09-27Kilby Cream Ice Cream, Island Breeze Size: 2.5 GalKilby CreamAccording to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage.Class II
2017-09-27Kilby Cream Ice Cream, Minty Moo Size: 2.5 Gal , 7 oz.Kilby CreamAccording to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage.Class II
2017-09-27Kilby Cream Ice Cream, Black Cherry Size: 7 oz. and Gallon, PintKilby CreamAccording to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage.Class II
2017-09-27Kilby Cream Ice Cream, Black Raspberry Size: 7 oz. and Gallon, PintKilby CreamAccording to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage.Class II
2017-09-27Kilby Cream Ice Cream Various Flavors: S'mores Size: 2.5 GalKilby CreamAccording to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage.Class II
2017-09-27Kilby Cream Ice Cream Various Flavors: Snickers Size: 2.5 GalKilby CreamAccording to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage.Class II
2017-09-27Kilby Cream Ice Cream, Calfiene Size: PintKilby CreamAccording to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage.Class II

All 35 records for Kilby Cream

All 2017 recalls · All FDA food recall data

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.

Early access

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.