Daily Wheat Bread, each loaf has a net wt. 24 oz.. The UPC is code and 6 36428 50500 3.
Great Northern Bakehouse Inc. dba Le Petit Outre recalled this product and the FDA reported the enforcement action on 25 January 2017 as Class II. The recall was initiated by the firm. Daily Wheat Bread is recalled due to undeclared soy lecithin. The soy allergen is present in DDA pan spray (release agent) and the firm used it to spray the loaf pans.
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
- Daily Wheat Bread, each loaf has a net wt. 24 oz.. The UPC is code and 6 36428 50500 3.
- Reason for recall
- Daily Wheat Bread is recalled due to undeclared soy lecithin. The soy allergen is present in DDA pan spray (release agent) and the firm used it to spray the loaf pans.
- Recalling firm
- Great Northern Bakehouse Inc. dba Le Petit Outre
- Firm location
- Missoula, Montana, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1255-2017
- Quantity
- 24 units
- Distribution
- distributed in MT only
- Initiated
- 14 December 2016
- Reported by FDA
- 25 January 2017
- Terminated
- 9 February 2017
- Firm notified by
- Letter
- Product codes
- Pull by date of 12/15, 12/16, 12/17, and 12/18.
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 7 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 7 separate recalls, which almost every published figure does, overstates it by a factor of 7. 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 7 of them.
- The recall ran for 8 weeks, from 14 December 2016 to termination on 9 February 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 FDA published the enforcement report 6 weeks after the firm began the recall.
- Recalls of a bakery product run a median of 6 months, so this one was shorter than usual for its category. Bakery is overwhelmingly an allergen category rather than a pathogen one: baking is a kill step, but a bakery runs many recipes down shared lines, so the failure that recalls a bakery product is usually a label or a changeover.
What this recall was for
Undeclared allergens
An undeclared allergen recall means a food contained one of the major allergens and the label did not say so, either because the wrong label was applied or because an ingredient carried an allergen nobody traced.
A preventive controls plan covers an undeclared allergen 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)(2)
- Food allergen controls: the written preventive controls that keep an allergen out of a food it does not belong in, and that get the allergens present onto the label.
- 21 CFR 101.4
- Ingredient declaration: every ingredient listed by its common name, in descending order of predominance, on the label of a packaged food.
- 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.
The allergens named in this record: soy, wheat.
Filed under bakery. A product can sit in more than one.
Other bakery 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 Great Northern Bakehouse Inc. dba Le Petit Outre
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 6 other records name this firm.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2017-01-25 | Whole Wheat Bread, each loaf has a net wt. 32 oz.. The UPC is code 6 36428 50200 2. | Great Northern Bakehouse Inc. dba Le Petit Outre | Whole Wheat Bread is recalled due to undeclared soy lecithin. The soy allergen is present in DDA pan spray (release agent) and the firm used it to spray the loaf pans. | Class II |
| 2017-01-25 | Birdman Bread, each loaf has net wt. 24 oz and 32 oz.. The UPC code ia 6 36428 10200 4. | Great Northern Bakehouse Inc. dba Le Petit Outre | Birdman Bread is recalled due to undeclared soy lecithin. The soy allergen is present in DDA pan spray (release agent) and the firm used it to spray the loaf pans. | Class II |
| 2017-01-25 | Italian Deli Loaf, each loaf has a net wt. 32 oz.. The UPC is code 6 36428 50200 2. | Great Northern Bakehouse Inc. dba Le Petit Outre | Italian Deli Loaf is recalled due to undeclared soy lecithin. The soy allergen is present in DDA pan spray (release agent) and the firm used it to spray the loaf pans. | Class II |
| 2017-01-25 | Sourdough Deli Loaf, each loaf has a net wt. 28 oz.. The UPC is code 6 36428 50200 2 | Great Northern Bakehouse Inc. dba Le Petit Outre | Sourdough Deli Loaf is recalled due to undeclared soy lecithin. The soy allergen is present in DDA pan spray (release agent) and the firm used it to spray the loaf pans. | Class II |
| 2017-01-25 | Brewers Grain Deli Loaf, each loaf has a net wt. 24 oz.. The UPC code is 6 36428 10300 1. | Great Northern Bakehouse Inc. dba Le Petit Outre | Brewers Grain Deli Loaf is recalled due to undeclared soy lecithin. The soy allergen is present in DDA pan spray (release agent) and the firm used it to spray the loaf pans. | Class II |
| 2017-01-25 | NY Rye Deli Loaf, each loaf has a net wt. 32 oz.. No UPC as this is for food service only. | Great Northern Bakehouse Inc. dba Le Petit Outre | NY Rye Deli Loaf is recalled due to undeclared soy lecithin. The soy allergen is present in DDA pan spray (release agent) and the firm used it to spray the loaf pans. | Class II |
All 7 records for Great Northern Bakehouse Inc. dba Le Petit Outre
All 2017 recalls · All FDA food recall data
21 CFR 117.135(c)(2) 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.