Dole" Organic Romaine Hearts 3pk Organic Biologique) (UPC 0-71430-90061-1), Wild Harvest…
Dole Fresh Vegetables Inc recalled this product and the FDA reported the enforcement action on 9 December 2020 as Class I. The recall was initiated by the firm. Pathogenic non-O157 E.coli STEC found during routine sampling by Michigan Department of Agriculture and Rural Development.
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
- Dole" Organic Romaine Hearts 3pk Organic Biologique) (UPC 0-71430-90061-1), Wild Harvest Organic Romaine Hearts, Net Wt 12 oz. (UPC 7-11535-50201-2),
- UPC
- 071430900611
- Reason for recall
- Pathogenic non-O157 E.coli STEC found during routine sampling by Michigan Department of Agriculture and Rural Development.
- Recalling firm
- Dole Fresh Vegetables Inc
- Firm location
- Monterey, California, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-0144-2021
- Quantity
- 2,203 cases
- Distribution
- U.S. distribution to the following: AZ, HI, IA, IL, IN, KS, MI, MN, MO, MS, MT, NC, ND, and VA No foreign distribution.
- Initiated
- 21 November 2020
- Reported by FDA
- 9 December 2020
- Terminated
- 4 February 2021
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Harvest dates of 10-23-20 and 10-26-20 UPC: 071430900611, LOT: 20OFIHOM17C300 UPC: 071430900611, LOTS: 20OFIHOM17C297 and 20OFIHOM17C300 UPC: 711535502012, LOTS: 20OFIHOM17C297 and 20OFIHOM17C300
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class I means the FDA judged a reasonable probability that the product would cause serious health consequences or death. 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 2 months, from 21 November 2020 to termination on 4 February 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 12 states, and 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.
Named in the distribution pattern: Hawaii, Iowa, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota. 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
E. coli
Shiga toxin-producing E. coli recalls concentrate in foods eaten raw or lightly cooked, where no step in the process is hot enough or long enough to be a kill step.
A preventive controls plan covers E. coli 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 117.135(c)(1)
- Process controls: the controls that apply a treatment, such as a validated kill step, at the point where it reduces the hazard to a safe level.
- 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.
- 21 CFR 120
- Juice HACCP: the hazard analysis and critical control point system required for juice processors, including a treatment achieving a 5-log pathogen reduction.
Other records from Dole Fresh Vegetables Inc
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 229 other records name this firm.
All 230 records for Dole Fresh Vegetables Inc
All 2020 recalls · All FDA food recall data
21 CFR 117.135(c)(1) 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 accessRecall 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.