White Polenta, San Gennaro brand, 12/16oz packages, UPC# 7-62676-17400-2 White Polenta…
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
White Polenta, San Gennaro brand, 12/16oz packages, UPC# 7-62676-17400-2 White Polenta, San Gennaro brand, 6/16oz packages UPC# 7-62676-17400-2 Ingredients: Water, White Corn Meal, Salt, Tartaric Acid
UPC
762676174002
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.
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
030618, 050818
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 a spice or seasoning run a median of 6 months, so this one was about typical for its category. Spices are a low-moisture, globally sourced, minimally processed ingredient that is added after any kill step, which is the combination that makes Salmonella in a spice lot capable of contaminating every product it was blended into.
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.
Other spices and seasonings 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
