Class IITerminated · reported 2018-05-16

Budget $aver Monster Cherry-Pineapple Pops Net Contents 36 FL OZ

Ziegenfelder Company, Inc. recalled this product and the FDA reported the enforcement action on 16 May 2018 as Class II. The recall was initiated by the firm. The Colorado Department of Public Health & Environment notified the firm that they had recovered Listeria monocytogenes from multiple environmental sampling sites collected during an inspection at their Denver plant.

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
Budget $aver Monster Cherry-Pineapple Pops Net Contents 36 FL OZ
Reason for recall
The Colorado Department of Public Health & Environment notified the firm that they had recovered Listeria monocytogenes from multiple environmental sampling sites collected during an inspection at their Denver plant.
Recalling firm
Ziegenfelder Company, Inc.
Firm location
Wheeling, West Virginia, United States
Classification
Class II
Status
Terminated
Recall number
F-1399-2018
Quantity
2,340 cases
Distribution
Product distributed to retail stores and distributors in Alabama, Arkansas, Florida, Maine, Missouri, Nebraska, Nevada, New Mexico, New York, Ohio, Oklahoma, Texas, Utah, Washington and Wyoming.
Initiated
23 April 2018
Reported by FDA
16 May 2018
Terminated
25 July 2019
Firm notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes
Lot codes D09418A through D10018B

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 2 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 2 separate recalls, which almost every published figure does, overstates it by a factor of 2. All 2 of them are listed on this page.
  • The recall ran for 15 months, from 23 April 2018 to termination on 25 July 2019. 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 FDA published the enforcement report 3 weeks after the firm began the recall.
  • The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.

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.

Every product in this recall

The FDA opened 2 enforcement records for this one recall, one per product code. This page carries all of them; the 1 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.

The other 1 records of FDA event 79931
ReportedProductFirmReasonClass
2018-05-16Budget $aver Sugar Free Twin Pops Net Contents 28.2 FL OZZiegenfelder Company, Inc.The Colorado Department of Public Health & Environment notified the firm that they had recovered Listeria monocytogenes from multiple environmental sampling sites collected during an inspection at their Denver plant.Class II

Other records from Ziegenfelder Company, Inc.

The FDA opens one enforcement record per product code, so several of these are frequently one recall event.

ReportedProductFirmReasonClass
2018-05-16Budget $aver Sugar Free Twin Pops Net Contents 28.2 FL OZZiegenfelder Company, Inc.The Colorado Department of Public Health & Environment notified the firm that they had recovered Listeria monocytogenes from multiple environmental sampling sites collected during an inspection at their Denver plant.Class II

All 2018 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 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.