Class IITerminated · reported 2019-09-11

Sweet Basil Farm Hawaii

First Rate Plantation recalled this product and the FDA reported the enforcement action on 11 September 2019 as Class II. The recall was initiated by the firm. FDA sampling found Cyclospora cayentanesis in the product.

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: Sweet Basil Farm Hawaii
Reason for recall: FDA sampling found Cyclospora cayentanesis in the product.
Recalling firm: First Rate Plantation
Firm location: Waianae, Hawaii, United States
Classification: Class II
Status: Terminated
Recall number: F-2100-2019
Quantity: 190 lbs.
Distribution: CO and MI
Initiated: 7 August 2019
Reported by FDA: 11 September 2019
Terminated: 3 September 2019
Firm notified by: Telephone
Product codes: lot # 20190722A8

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 weeks, from 7 August 2019 to termination on 3 September 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 distribution pattern names 2 states, 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.

Named in the distribution pattern: Colorado, Michigan. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.

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 2019 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.