Class IITerminated · reported 2020-12-30

Organic Basil,15 bags, Net. Wt.15Lbs case.

Vallarta Organics LLC recalled this product and the FDA reported the enforcement action on 30 December 2020 as Class II. The recall was initiated by the firm. Possible contamination with Cyclospora

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: Organic Basil,15 bags, Net. Wt.15Lbs case.
Reason for recall: Possible contamination with Cyclospora
Recalling firm: Vallarta Organics LLC
Firm location: Coral Gables, Florida, United States
Classification: Class II
Status: Terminated
Recall number: F-0185-2021
Quantity: 280 boxes/4200 pounds
Distribution: Distributed to direct accounts in VA and FL
Initiated: 27 November 2020
Reported by FDA: 30 December 2020
Terminated: 29 April 2021
Firm notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes: Lot#LP814

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 5 months, from 27 November 2020 to termination on 29 April 2021. 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 1 state, and the FDA published the enforcement report 5 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

Viral and parasitic contamination

Hepatitis A, norovirus and Cyclospora recalls trace back to a person or to water rather than to the process: an infected food handler, or produce irrigated or washed with contaminated water.

A preventive controls plan covers viral or parasitic 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 117.10: Personnel: the hygiene practices, and the exclusion of anyone with an illness or open lesion that could contaminate food, that a facility must require.
21 CFR 112: Produce safety: the agricultural water, worker health and hygiene standards for farms growing produce eaten raw.
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.

All 2020 recalls · All FDA food recall data

21 CFR 117.10 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.