Class IITerminated · reported 2024-10-02

Bacalaitos Criollos, CODFISH FRYING MIX, 7 oz., packaged in a plastic bag, 24 packages…

Avole, Inc. recalled this product and the FDA reported the enforcement action on 2 October 2024 as Class II. The recall was initiated by the firm. Allergen not listed in the Contains statement: Fish

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: Bacalaitos Criollos, CODFISH FRYING MIX, 7 oz., packaged in a plastic bag, 24 packages (units) per cases of 7 onz.
Reason for recall: Allergen not listed in the Contains statement: Fish
Recalling firm: Avole, Inc.
Firm location: San Sebastian, Puerto Rico, United States
Classification: Class II
Status: Terminated
Recall number: F-1835-2024
Quantity: 100 Boxes of 24 units per box for a total of 2,400 units
Distribution: Within Puerto Rico only. No foreign distribution.
Initiated: 9 September 2024
Reported by FDA: 2 October 2024
Terminated: 15 January 2025
Firm notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes: 310925 EXP.06/2025

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 record is the only one the FDA opened for its recall event, so it covers a single product code.
The recall ran for 4 months, from 9 September 2024 to termination on 15 January 2025. 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: fish.

All 2024 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.