Sundried Tomato Polenta, San Gennaro brand, Pre-cooked Ready to Heat & Serve, 12/24 oz…
San Gennaro Foods, Inc recalled this product and the FDA reported the enforcement action on 15 November 2017 as Class III. The recall was initiated by the firm. Date coding ink was being printed directly on the food contact surface of packaging, allowing the ink to be in direct contact with the product. The ink is not approved for food use.
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
- Sundried Tomato Polenta, San Gennaro brand, Pre-cooked Ready to Heat & Serve, 12/24 oz packages, UPC# 7-62676-12401-4 Sundried Tomato Polenta, San Gennaro brand, Pre-cooked Ready to Heat & Serve, 12/18 oz packages, UPC# 7-62676-15001-3 Sundried Tomato Polenta, San Gennaro Canadian brand, Ready to Heat & Serve,1 2/24 oz UPC# 7-62676-12401-4 Ingredients: Water, Yellow Corn Meal, Sun-Dried Tomatoes, Dehydrated Garlic, Salt, Tartaric Acid, Ascorbic Acid, Beta Carotene
- UPC
- 762676124014
- Reason for recall
- Date coding ink was being printed directly on the food contact surface of packaging, allowing the ink to be in direct contact with the product. The ink is not approved for food use.
- Recalling firm
- San Gennaro Foods, Inc
- Firm location
- Kent, Washington, United States
- Classification
- Class III
- Status
- Terminated
- Recall number
- F-0129-2018
- Quantity
- 12/24oz=532 cases; 12/18oz=581.5; 12/24oz Canadian=76
- Distribution
- CA, CO, FL, GA, IL, IN, MD, ME, MI, NJ, NY, OR, PA, SC, TX, VA, WA, WI and Canada.
- Initiated
- 13 October 2017
- Reported by FDA
- 15 November 2017
- Terminated
- 18 May 2018
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- 12/24oz codes: 012518, 022118, 032018, 051418, 062718. 12/18oz codes: 012218, 022118, 040218, 042518, 052918. 12/24oz Canadian codes: 18FE14, 2018MR20.
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class III means the FDA judged that the product was unlikely to cause harm but violated FDA labelling or manufacturing regulation. 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 14 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 14 separate recalls, which almost every published figure does, overstates it by a factor of 14. 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 14 of them.
- The recall ran for 7 months, from 13 October 2017 to termination on 18 May 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 distribution pattern names 18 states, and 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 about typical 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.
Named in the distribution pattern: California, Colorado, Florida, Georgia, Illinois, Indiana, Maryland, Maine, Michigan, New Jersey, New York, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington, Wisconsin. 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
Unapproved ingredients
An unapproved ingredient recall means a product contained a substance not permitted in food, most often an undisclosed pharmaceutical active found in a dietary supplement.
A preventive controls plan covers an unapproved ingredient 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 111
- Dietary supplement CGMP: the identity, purity, strength and composition specifications a supplement manufacturer sets and verifies for every component and finished batch.
- 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, spices and seasonings and prepared meals and sandwiches. 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 San Gennaro Foods, Inc
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 13 other records name this firm.
All 14 records for San Gennaro Foods, Inc
All 2017 recalls · All FDA food recall data
21 CFR 111 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.