Class IIITerminated · reported 2021-10-06

Crunchy Cones, Mix Choco-Vanilla, 12, NET WT 40oz (113g)

Borinquen Cones of Puerto Rico, Inc. recalled this product and the FDA reported the enforcement action on 6 October 2021 as Class III. The recall was initiated by the firm. Undeclared sulfites in product label.

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
Crunchy Cones, Mix Choco-Vanilla, 12, NET WT 40oz (113g)
Reason for recall
Undeclared sulfites in product label.
Recalling firm
Borinquen Cones of Puerto Rico, Inc.
Firm location
Rio Piedras, Puerto Rico, United States
Classification
Class III
Status
Terminated
Recall number
F-1024-2021
Quantity
97 boxes
Distribution
Domestic distribution only.
Initiated
14 September 2021
Reported by FDA
6 October 2021
Terminated
15 February 2022
Firm notified by
Telephone
Product codes
Lot 24521 Use by Jan 20 2022

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

  • Class III means the FDA judged that the product was unlikely to cause harm but violated FDA labelling or manufacturing regulation. 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 5 months, from 14 September 2021 to termination on 15 February 2022. 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

Undeclared allergens

An undeclared allergen recall means a food contained one of the major allergens and the label did not say so, either because the wrong label was applied or because an ingredient carried an allergen nobody traced.

A preventive controls plan covers an undeclared allergen 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)(2)
Food allergen controls: the written preventive controls that keep an allergen out of a food it does not belong in, and that get the allergens present onto the label.
21 CFR 101.4
Ingredient declaration: every ingredient listed by its common name, in descending order of predominance, on the label of a packaged food.
21 CFR 117 subpart G
Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.

The allergens named in this record: sulfites.

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 88686
ReportedProductFirmReasonClass
2021-10-06Crunchy Cones, Chocolate, 12, NET WT 40oz (113g)Borinquen Cones of Puerto Rico, Inc.Undeclared sulfites in product label.Class III

Other records from Borinquen Cones of Puerto Rico, Inc.

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

ReportedProductFirmReasonClass
2021-10-06Crunchy Cones, Chocolate, 12, NET WT 40oz (113g)Borinquen Cones of Puerto Rico, Inc.Undeclared sulfites in product label.Class III

All 2021 recalls · All FDA food recall data

21 CFR 117.135(c)(2) 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.