Class ITerminated · reported 2017-07-19

PRIMO MOLINO ITALIAN STYLE ENRICHED FLOUR, 50 lb, Packaged in paper bags, Store at…

Ardent Mills, LLC recalled this product and the FDA reported the enforcement action on 19 July 2017 as Class I. The recall was initiated by the firm. Primo Molino Italian Style Flour may be contaminated with E. coli O121.

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
PRIMO MOLINO ITALIAN STYLE ENRICHED FLOUR, 50 lb, Packaged in paper bags, Store at Ambient Temperature, produced on 10/31/16, Product code 15031
Reason for recall
Primo Molino Italian Style Flour may be contaminated with E. coli O121.
Recalling firm
Ardent Mills, LLC
Firm location
Denver, Colorado, United States
Classification
Class I
Status
Terminated
Recall number
F-2426-2017
Quantity
487 bags
Distribution
Distributed to three locations. No Govt/VA/Military consignees. 380 bags to CH Gunther ( Pizza Blends) 1541 VERNON ST Kansas City MO 11/21/16 112 bags shipped to Nations Pizza 601 E ALGONQUIN RD SCHAUMBURG IL on 1/17/2017 5 bags shipped to AK Crust 1326 CORNELL RD Green Bay WI 11/30/16
Initiated
2 June 2017
Reported by FDA
19 July 2017
Terminated
7 August 2017
Firm notified by
Telephone
Product codes
Lot code- 6 305 SK

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 2 June 2017 to termination on 7 August 2017. 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 1 state, and the FDA published the enforcement report 7 weeks after the firm began the recall.
  • Recalls of a grain, flour or pasta product run a median of 6 months, so this one was shorter than usual for its category. Flour is a raw agricultural product that consumers treat as though it were cooked, which is the whole reason raw flour recalls exist: nothing in milling is a kill step, and the hazard only appears when somebody eats the dough.

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.

Filed under grains, flour and pasta. A product can sit in more than one.

Other grains, flour and pasta 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 Ardent Mills, LLC

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 9 other records name this firm.

ReportedProductFirmReasonClass
2022-06-08BBU Fine Whole Wheat Flour Bulk-AA-50251, Bulk Tanker; SG Whole Wheat Fine Flour 2,000 lb. Tote-AA Storage instructions - Any product made from raw agricultural commodities, such as wheat, rye and other grains, may be subject to infestation if not properly inspected when received, handled, and stored. To reduce the risk of infestation, customer should ensure it has proper goods receiving inspection procedures, and should store the product in a clean, dry area that is well ventilatedArdent Mills, LLCPotential to contain small pieces of stainless steel from a piece of milling equipment which was discovered during an investigative inspection of our system.Class II
2022-03-09Ardent Mills Hotel and Restaurant All Purpose Flour - AA, 50 lb. (22.68kg) bag, UPC 6 78008 00053 9, Ardent Mills, Denver, CO 80202. Milled in Alton, IL.Ardent Mills, LLCRaw, untreated flour tested positive for Salmonella.Class II
2020-02-26Kroger Unbleached All Purpose Enriched Flour, 5 lb. bag. Bar code: 011110861660Ardent Mills LLCProduct may be contaminated with Salmonella.Class II
2020-01-01Wild Harvest Organic Unbleached All Purpose Flour, Net Wt 5 lb. (2.26 kg) in paper bags, UPC 7 11535 50915 8, 8 bags per case.Ardent Mills LLCWild Harvest Organic Unbleached All Purpose Flour in 5 lb. bags has the potential to be contaminated with E. coli (STEC).Class II
2019-02-27MEMBERS MARK SELF RISE FLR 25LBArdent Mills, LLCArdent Mills is voluntarily recalling certain lots of Self-Rising Flour because it has the potential to be contaminated with Salmonella.Class II
2019-02-27WESTCREEK H&R SELF RISE AP FLR 25LB and 50LBArdent Mills, LLCArdent Mills is voluntarily recalling certain lots of Self-Rising Flour because it has the potential to be contaminated with Salmonella.Class II
2019-02-27HILLTOP HEARTH SELF RISE FLR 25LB and 50LBArdent Mills, LLCArdent Mills is voluntarily recalling certain lots of Self-Rising Flour because it has the potential to be contaminated with Salmonella.Class II
2019-02-27ARDENT H&R SR FLR, 25LB, 50 LB, and 25LB (PC)-309951, packaged in paper bags, Store at Ambient TemperatureArdent Mills, LLCArdent Mills is voluntarily recalling certain lots of Self-Rising Flour because it has the potential to be contaminated with Salmonella.Class II
2018-10-24Safeguard Soft Flr (GIV) packaged in 50 lb bagsArdent Mills, LLCFlour tested positive for Salmonella by customer.Class II

All 10 records for Ardent Mills, LLC

All 2017 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 access

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.