Class IIITerminated · reported 2021-12-01

Mr. Special Jugo de Pina De Concentrado, 46 oz cans, packaged cardboard boxes 12 cans…

Empresas La Famosa, Inc. recalled this product and the FDA reported the enforcement action on 1 December 2021 as Class III. The recall was initiated by the firm. Discovered swollen cans

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: Mr. Special Jugo de Pina De Concentrado, 46 oz cans, packaged cardboard boxes 12 cans per case of 46 oz each
Reason for recall: Discovered swollen cans
Recalling firm: Empresas La Famosa, Inc.
Firm location: Toa Baja, Puerto Rico, United States
Classification: Class III
Status: Terminated
Recall number: F-0216-2022
Quantity: 409 cases 12/46 oz cans
Distribution: Domestic distribution only: Puerto Rico
Initiated: 23 August 2021
Reported by FDA: 1 December 2021
Terminated: 9 March 2022
Firm notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes: P1105A2PDT03, Exp. Apr/ 15/ 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 record is the only one the FDA opened for its recall event, so it covers a single product code.
The recall ran for 7 months, from 23 August 2021 to termination on 9 March 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 months 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

Spoilage and mould

A spoilage recall means the food degraded before its date: mould growth, unintended fermentation, swelling or rancidity, usually traced to a seal, a formulation or a storage temperature.

A preventive controls plan covers spoilage 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 117.93: Warehousing and distribution: storage and transport under conditions that protect food against contamination and against deterioration of the food and its container.
21 CFR 117.80(b)(3): Time and temperature: holding food at temperatures that do not allow microorganisms to grow, and for no longer than the process allows.

All 2021 recalls · All FDA food recall data

21 CFR 117.93 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.