Krispy Kreme Doughnuts, Glazed Mini Crullers, Net Wt. 10 oz, Manufactured under the…
krispy kreme doughnut corporation recalled this product and the FDA reported the enforcement action on 13 December 2017 as Class II. The recall was initiated by the firm. Foreign Matter (a 1/8 long x 8mm, white & blue strand) found on product.
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
Krispy Kreme Doughnuts, Glazed Mini Crullers, Net Wt. 10 oz, Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston-Salem, NC 27102.
Reason for recall
Foreign Matter (a 1/8 long x 8mm, white & blue strand) found on product.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes
Products manufactured on 11/01/2017, with Sell by Date: 11/07/2017.
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 6 weeks, from 2 November 2017 to termination on 11 December 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 2 states, and 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.
Named in the distribution pattern: Georgia, South Carolina. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.
A foreign material recall means something that is not food was found in food: metal, plastic, glass, wood or insect matter, usually shed by equipment during processing.
A preventive controls plan covers foreign material 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 117.40
Equipment and utensils: plant equipment designed and maintained so it cannot contaminate food with lubricants, fuel, metal fragments or contaminated water.
21 CFR 117.80(c)
Manufacturing operations: the measures that protect food from contamination during processing, including the effective ones against metal and other extraneous material.
21 CFR 117.150
Corrective actions: what a facility does when a preventive control was not properly implemented, including identifying and correcting the problem and evaluating the food for safety.
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.
Metal fragments in bread. The firm discovered metal fragments in various bread products. They determined the cause to be roasted tomatoes provided by one of their ingredient suppliers.
Downstream recall. Product contains arrowroot flour ingredient that was voluntarily recalled by the supplier due to potential contamination of soft kraft paper/plastic bag pieces.
21 CFR 117.40 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.
