Kilby Cream Ice Cream Various Flavors: , Vanilla 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: , Vanilla 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-3553-2017
- Quantity
- 21 units
- 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
- 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.
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.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2017-09-27 | Kilby Cream Ice Cream Various Flavors: Strawberry Cheesecake Size: 2.5 Gal , 7 oz. | Kilby Cream | According to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage. | Class II |
| 2017-09-27 | Kilby Cream Ice Cream, Crow Vineyard Rose Size: 2.5 Gal | Kilby Cream | According to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage. | Class II |
| 2017-09-27 | Kilby Cream Ice Cream, Island Breeze Size: 2.5 Gal | Kilby Cream | According to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage. | Class II |
| 2017-09-27 | Kilby Cream Ice Cream, Minty Moo Size: 2.5 Gal , 7 oz. | Kilby Cream | According to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage. | Class II |
| 2017-09-27 | Kilby Cream Ice Cream, Black Cherry Size: 7 oz. and Gallon, Pint | Kilby Cream | According to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage. | Class II |
| 2017-09-27 | Kilby Cream Ice Cream, Black Raspberry Size: 7 oz. and Gallon, Pint | Kilby Cream | According to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage. | Class II |
| 2017-09-27 | Kilby Cream Ice Cream Various Flavors: S'mores Size: 2.5 Gal | Kilby Cream | According to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage. | Class II |
| 2017-09-27 | Kilby Cream Ice Cream Various Flavors: Snickers Size: 2.5 Gal | Kilby Cream | According to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage. | Class II |
| 2017-09-27 | Kilby Cream Ice Cream, Calfiene Size: Pint | Kilby Cream | According to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage. | Class II |
| 2017-09-27 | Kilby Cream Ice Cream, Birthday Cake Size: 7 oz. and Gallon, Pint | Kilby Cream | According 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 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.