Mexicantown Wholesale recalled this product and the FDA reported the enforcement action on 11 July 2012 as Class I. The recall was initiated by the firm. The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared soy (soy flour and soybean oil).
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
MUFFIN PLAIN (MEXICAN SWEET BREAD) IMPORTED BY ELCAMPEON LEAMINGTON 519-324-2616 4oz, UPC: 9564000029; and item #001
UPC
9564000029
Reason for recall
The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared soy (soy flour and soybean oil).
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 is one of 18 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 18 separate recalls, which almost every published figure does, overstates it by a factor of 18. 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 18 of them.
The recall ran for 6 months, from 21 May 2012 to termination on 19 November 2012. 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 7 weeks after the firm began the recall.
Recalls of a bakery product run a median of 6 months, so this one was about typical 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.
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.
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.
The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat, soy, milk, eggs and tree nut (coconut).
The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat, soy, milk, eggs and tree nut (coconut).
Undeclared Soy. The firm received complaints of sausage in the burritos. Upon review the firm discovered the sausage contains soy which is not listed on the label.
The firm recalled 26 products for undeclared allergens. this product was recalled due to undeclared soy (soy four and soybean oil) and milk (nonfat milk).
The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared wheat (flour), milk, and soy (soybean oil and soy flour).
The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared milk (nonfat milk), Soy (soybean oil and soy flour), FD&C yellow #6, and wheat (flour).
The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared milk (liquid milk added), FD&C yellow #6, and wheat (flour).
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.
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.
