Blue Bunny Ice Cream Hoppin' Holidoodle ice cream 46 fl. oz. UPC 070640014644 and UPC…
Wells Enterprises, Inc. recalled this product and the FDA reported the enforcement action on 30 November 2016 as Class I. The recall was initiated by the firm. Product may be contaminated with Listeria Monocytogenes.
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
- Blue Bunny Ice Cream Hoppin' Holidoodle ice cream 46 fl. oz. UPC 070640014644 and UPC 070640014651 (high altitude).
- UPC
- 070640014644
- Reason for recall
- Product may be contaminated with Listeria Monocytogenes.
- Recalling firm
- Wells Enterprises, Inc.
- Firm location
- Le Mars, Iowa, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-0479-2017
- Quantity
- 7192 cases
- Distribution
- Product was distributed to NE, OK, KS, MO, AZ, and TX.
- Initiated
- 10 October 2016
- Reported by FDA
- 30 November 2016
- Terminated
- 5 January 2017
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- UPC 070640014644 LOT 60001 MM 19115 6228 BEST IF USED BY 02/13/18; and UPC 070640014651 (High altitude) LOT 60001 MM 19115 6229 BEST IF USED BY 02/14/18
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 record is the only one the FDA opened for its recall event, so it covers a single product code.
- The recall ran for 3 months, from 10 October 2016 to termination on 5 January 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 5 states, and the FDA published the enforcement report 7 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: Oklahoma, Kansas, Missouri, Arizona, Texas. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.
What this recall was for
Listeria monocytogenes
Listeria monocytogenes is a bacterium that grows at refrigeration temperature, which is why it dominates recalls of ready-to-eat foods that are never cooked again before they are eaten.
A preventive controls plan covers Listeria contamination 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)(3)
- Sanitation controls: the controls on cleaning food-contact surfaces and on preventing cross-contact and cross-contamination from insanitary objects, people and equipment.
- 21 CFR 117.165(a)(3)
- Environmental monitoring: testing the processing environment for an environmental pathogen, required when a ready-to-eat food is exposed to the environment before packaging.
- 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 Wells Enterprises, Inc.
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 24 other records name this firm.
All 25 records for Wells Enterprises, Inc.
All 2016 recalls · All FDA food recall data
21 CFR 117.135(c)(3) 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.