Class IITerminated · reported 2018-08-08

Cold Dough Premix 6.8 pound bag, 6 units per carton Item 127033700

Griffith Labs U.S.A. recalled this product and the FDA reported the enforcement action on 8 August 2018 as Class II. The recall was initiated by the firm. Potential presence of Salmonella due to use of recalled whey ingredient

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: Cold Dough Premix 6.8 pound bag, 6 units per carton Item 127033700
Reason for recall: Potential presence of Salmonella due to use of recalled whey ingredient
Recalling firm: Griffith Labs U.S.A.
Firm location: Alsip, Illinois, United States
Classification: Class II
Status: Terminated
Recall number: F-1868-2018
Quantity: 193 cases, 7874.4 lbs
Distribution: Nationwide and Canada
Initiated: 17 July 2018
Reported by FDA: 8 August 2018
Terminated: 20 May 2020
Firm notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes: Batch or lot numbers: 673958 673959

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 is one of 43 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 43 separate recalls, which almost every published figure does, overstates it by a factor of 43. 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 43 of them.
The recall ran for 22 months, from 17 July 2018 to termination on 20 May 2020. 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 3 weeks after the firm began the recall.
The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.

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.

Other records from Griffith Labs U.S.A.

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 42 other records name this firm.

Reported	Product	Firm	Reason	Class
2018-08-08	Caesar Seasoning 50 pound bag Item 1000031193	Griffith Labs U.S.A.	Potential presence of Salmonella due to use of recalled whey ingredient	Class II
2018-08-08	Brown Gravy Mix 16 oz unit, 24 units per carton Item 1000011214	Griffith Labs U.S.A.	Potential presence of Salmonella due to use of recalled whey ingredient	Class II
2018-08-08	Cheese and Garlic Crouton Seasoning 50 pound bag Item 1000023919	Griffith Labs U.S.A.	Potential presence of Salmonella due to use of recalled whey ingredient	Class II
2018-08-08	Cheese and Garlic Crouton Seasoning 50 pound bag Item 859019400	Griffith Labs U.S.A.	Potential presence of Salmonella due to use of recalled whey ingredient	Class II
2018-08-08	Reduced Whey Cold Dough Premix 2.3 pound bag, 18 units per carton Item 127038500	Griffith Labs U.S.A.	Potential presence of Salmonella due to use of recalled whey ingredient	Class II
2018-08-08	Queso Snack Seasoning 25 pound bag, 1 bags per carton Item 1000033198	Griffith Labs U.S.A.	Potential presence of Salmonella due to use of recalled whey ingredient	Class II
2018-08-08	Herb Crouton Seasoning 50 pound bag Item 702046300	Griffith Labs U.S.A.	Potential presence of Salmonella due to use of recalled whey ingredient	Class II
2018-08-08	Asiago Peppercorn 50 pound bag, Item 859081400	Griffith Labs U.S.A.	Potential presence of Salmonella due to use of recalled whey ingredient	Class II
2018-08-08	Sour Cream & Onion Snack Seasoning 200 pound drum Item 702083400	Griffith Labs U.S.A.	Potential presence of Salmonella due to use of recalled whey ingredient	Class II
2018-08-08	Butter Garlic Crouton Seasoning 50 pound bag, Item 859061100	Griffith Labs U.S.A.	Potential presence of Salmonella due to use of recalled whey ingredient	Class II

All 43 records for Griffith Labs U.S.A.

All 2018 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.