Built Bar, Banana Cream Pie Puffs Protein Bar, 1.41 oz. (40 g) net wt., packaged in…
BUILT BRANDS LLC recalled this product and the FDA reported the enforcement action on 13 July 2022 as Class I. The recall was initiated by the firm. Banana Cream Pie Puff Protein Bars have the potential to be contaminated with Escherichia 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
Built Bar, Banana Cream Pie Puffs Protein Bar, 1.41 oz. (40 g) net wt., packaged in individual wrapper, Built Brands, LLC, 600 E Quality Dr., American Fork, UT 84003. SKU 30000318. Product sold as part of a paperboard 12-count mixed box. Each box contains 4 affected bars. UPC 8 40229 30053 2. Product is intended for ambient storage and is ready to eat.
UPC
840229300532
Reason for recall
Banana Cream Pie Puff Protein Bars have the potential to be contaminated with Escherichia coli.
Lot # D22151011 Best by date: 03/02/2023 Due to variations in equipment on the production line, the lot code and best by date can be found on either the top or bottom of the wrapper near one of the crimped ends. Explanation of code: D = product is for domestic use only; 22 = year product manufactured; 151 = Julian date product manufactured; 01 = production line; 1 = shift product manufactured
Reading this record
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 record is the only one the FDA opened for its recall event, so it covers a single product code.
The recall ran for 18 months, from 8 June 2022 to termination on 8 December 2023. 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 5 weeks after the firm began the recall.
Recalls of milk or a dairy product run a median of 7 months, so this one was longer than usual for its category. Dairy recalls split between pathogen contamination in products that skipped or under-ran pasteurisation and undeclared milk in products that should never have contained it, which is the same allergen viewed from two directions.
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.
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.
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.
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.
