Red Leaf Lettuce was shipped in card board boxes that are labeled with the firm name…
Howard Calcagno Farms recalled this product and the FDA reported the enforcement action on 5 September 2018 as Class II. The recall was initiated by the firm. Red Leaf Lettuce is recalled due to a potential for contamination with Cyclospora cayetanensis.
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
- Red Leaf Lettuce was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
- Reason for recall
- Red Leaf Lettuce is recalled due to a potential for contamination with Cyclospora cayetanensis.
- Recalling firm
- Howard Calcagno Farms
- Firm location
- Aurora, Oregon, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1916-2018
- Quantity
- 2 dozens
- Distribution
- distributed in Oregon
- Initiated
- 13 August 2018
- Reported by FDA
- 5 September 2018
- Terminated
- 6 November 2018
- Firm notified by
- Telephone
- Product codes
- None
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 is one of 19 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 19 separate recalls, which almost every published figure does, overstates it by a factor of 19. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 19 of them.
- The recall ran for 3 months, from 13 August 2018 to termination on 6 November 2018. 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.
- Recalls of fresh produce run a median of 7 months, so this one was shorter than usual for its category. Fresh produce is the category where contamination arrives before the facility does: irrigation water, soil amendments and field workers are the routes, and nothing downstream of the farm is a kill step for a product eaten raw.
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.
Filed under fresh produce. A product can sit in more than one.
Other fresh produce recalls for the same reason
These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Other records from Howard Calcagno Farms
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 18 other records name this firm.
All 19 records for Howard Calcagno Farms
All 2018 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 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.