Whole cantaloupe, Brand name Malichita 11 count carton, 8 count carton, 9 count carton…
Sofia Produce, L.L.C. recalled this product and the FDA reported the enforcement action on 13 December 2023 as Class I. The recall was initiated by the firm. The affected product is being recalled from the marketplace due to possible Salmonella contamination.
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
- Whole cantaloupe, Brand name Malichita 11 count carton, 8 count carton, 9 count carton, 15 count carton d. Container description; Red Corrugated Paper Carton or Black Plastic RPC.
- Reason for recall
- The affected product is being recalled from the marketplace due to possible Salmonella contamination.
- Recalling firm
- Sofia Produce, L.L.C.
- Firm location
- Nogales, Arizona, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-0568-2024
- Quantity
- 12,706 boxes original recall. 5,649 boxes for the expanded recall. Totaling 18,335 boxes.
- Distribution
- Customers are located in the United States & Canada. There is no distribution to US Government agencies or departments. Product was distributed to consignees in the following states: California, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Ohio, South Dakota, Tennessee, Texas, Virginia, West Virginia, Wisconsin and Washington D.C.
- Initiated
- 6 November 2023
- Reported by FDA
- 13 December 2023
- Terminated
- 17 September 2024
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Our information corresponding to Lot Codes is our Order Number. Order Numbers: 0128556, 0128624, 0128630, 0128632, 0128640, 0128643, 0128644, 0128646, 0128648, 0128651, 0128656, 0128669, 0128680, 0128682, 0128683, 0128700, 0225200, 0225201, 0225206, 0225214, 0225219, 0225222, 0225226, 0225227, 0225228, 0419611, 0419629, 0419630, 0419636, 0419671, 0419688, 0419693, 0419696, 0419697, 0419704, 0419710, 0419718, 0419772, 0516255, 0516268, 0516271, 0516279, 0516301, 0612143, 0612144, 0612148, 0612154, 0612156, 0612158, 0612171, 0612190, 0612191, 0612197, 0612198, 0612209, 0612225 Above Order Numbers are all those associated with all shipments which could have contained products related to the Canadian Recall. On 11/14/2023 TruFresh expanded the recall to include the following Sales order numbers associated with the lots that tested positive in Canada. 128663,128712,128713,128662 ,128680 ,225252 ,225231 ,419719,419721,419828,419803,612235 612273
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 is one of 2 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 2 separate recalls, which almost every published figure does, overstates it by a factor of 2. 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 2 of them.
- The recall ran for 10 months, from 6 November 2023 to termination on 17 September 2024. 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 5 weeks after the firm began the recall.
- Recalls of fresh produce run a median of 7 months, so this one was longer 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
Salmonella
Salmonella is a bacterium that survives in low-moisture foods for months, which is why it appears in recalls of products that carry no water for it to grow in: nut butters, spices, flour and dry pet food.
A preventive controls plan covers Salmonella 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 117.165(a)(2)
- Product testing: testing as a verification activity, appropriate to the facility, the food and the nature of the preventive control.
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 Sofia Produce, L.L.C.
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2023-12-13 | Whole cantaloupe, Brand name Rudy 11 count carton, 8 count carton, 9 count carton, 15 count carton d. Container description; Cardboard containers bearing the Rudy label. The Rudy brand cantaloupes also have an individual PLU sticker placed upon each cantaloupe, PLU sticker # 4050. | Sofia Produce, L.L.C. | The affected product is being recalled from the marketplace due to possible Salmonella contamination. | Class I |
All 2023 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.