Class IITerminated · reported 2016-05-25

COMMERCIAL WHEAT GERM 274000, 50.00 lbs. (22.68 kg); UPC Code: 0-26938-46535-3

UNFI recalled this product and the FDA reported the enforcement action on 25 May 2016 as Class II. The recall was initiated by the firm. Product contains generic E. coli.

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: COMMERCIAL WHEAT GERM 274000, 50.00 lbs. (22.68 kg); UPC Code: 0-26938-46535-3
Reason for recall: Product contains generic E. coli.
Recalling firm: UNFI
Firm location: Chesterfield, New Hampshire, United States
Classification: Class II
Status: Terminated
Recall number: F-1363-2016
Quantity: 32 bags
Distribution: NY, RI, ME, MA, VT, OH, MN, IN, KY, MO, ME, SD, CT, IA, NE, WI, NJ
Initiated: 15 April 2016
Reported by FDA: 25 May 2016
Terminated: 16 May 2018
Firm notified by: Letter
Product codes: Lot Codes: W121915, W012116, W122315

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 record is the only one the FDA opened for its recall event, so it covers a single product code.
The recall ran for 2.1 years, from 15 April 2016 to termination on 16 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 16 states, and the FDA published the enforcement report 6 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 longer 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.

Named in the distribution pattern: New York, Rhode Island, Maine, Massachusetts, Vermont, Ohio, Minnesota, Indiana, Kentucky, Missouri, South Dakota, Connecticut, Iowa, Nebraska, Wisconsin, New Jersey. 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

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.

Reported	Product	Firm	Reason	Class
2020-02-19	King Arthur All Purpose Flour 25# bags	Adm Milling	E.coli O26	Class I
2020-02-19	H&R Flour, UNBL, EN, MT / Product Code 706220 in 50# bags	Adm Milling	E.coli O26	Class I
2020-02-19	Potentate flour / Prod Code: 802217 in 50# bags	Adm Milling	E.coli O26	Class I
2020-02-19	Bulk flour	Adm Milling	E.coli O26	Class I
2020-02-19	Commander Flour, Product Code 704220 in 50 lbs bags	Adm Milling	E.coli O26	Class I
2020-02-19	Bakers Corner All Purpose Flour in 5 lb. bags	Adm Milling	E.coli O26	Class I
2020-02-19	PB 25 LBS All Purpose Flour Product Code 806326	Adm Milling	E.coli O26	Class I
2020-02-19	Best Baker's flour 50 lbs bags	Adm Milling	E.coli O26	Class I

Other records from UNFI

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 5 other records name this firm.

Reported	Product	Firm	Reason	Class
2014-03-05	Kinnikinnick Kinni-Kwik Bread & Bun Mix-Weight 350g/16oz Cardboard Box UPC 62013310550 4	UNFI	Undeclared milk.	Class I
2014-03-05	Kinnikinnick Pancake & Waffle Mix -Weight: 454g/16 oz Cardboard Box UPC 62013310512 2	UNFI	Undeclared milk.	Class I
2014-03-05	Kinnikinnick Panko Style Bread Crumbs-Weight: 350g/12.5oz Cardboard Box UPC 62013360015 3	UNFI	Undeclared milk.	Class I
2014-03-05	Kinnikinnick Cinnamon & Brown Sugar Homestyle Waffles-Weight: 210 g/7.4oz Qty/Pkg: 6 Cardboard Box-UPC: 62013300199 8	UNFI	Undeclared milk.	Class I
2014-03-05	Kinnikinnick Original Homestyle Waffles-Weight: 210 g/7.4oz Qty/Pkg: 6 Cardboard Box-UPC: 62013300198 1	UNFI	Undeclared milk.	Class I

All 6 records for UNFI

All 2016 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.