Dark Chocolate Cranberries packaged in: Bulk 3.5 oz. Plastic Cup 4.75 oz.
Aurora Products, Inc. recalled this product and the FDA reported the enforcement action on 22 November 2017 as Class II. The recall was initiated by the firm. Product contains undeclared milk
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
- Dark Chocolate Cranberries packaged in: Bulk 3.5 oz. Plastic Cup 4.75 oz. Plastic Pouch 9 oz. Plastic Cup 9 oz. Plastic Pouch 11 oz. Square Plastic Tub 18 oz. Family Size Plastic Pouch 26 oz. Plastic Tray Aurora Brand and Store Branded Labeling Include: AG Supermarkets, Belmont Market, Boiceville Market, Deciccos, Grauls Market, Gourmet Garage, Harvest Co Op Market, Hurley Ridge, Lees Supermarket, Morton Williams, Palmers Market, Walter Stewart, Windfall Market and Whole Food Market.
- Reason for recall
- Product contains undeclared milk
- Recalling firm
- Aurora Products, Inc.
- Firm location
- Orange, Connecticut, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0340-2018
- Quantity
- 35,100 units
- Distribution
- Nationwide and Bermuda
- Initiated
- 1 November 2017
- Reported by FDA
- 22 November 2017
- Terminated
- 19 January 2018
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- BEST IF USED BY DATE CODE RANGE: 11/01/16 7/30/18
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 5 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 5 separate recalls, which almost every published figure does, overstates it by a factor of 5. All 5 of them are listed on this page.
- The recall ran for 3 months, from 1 November 2017 to termination on 19 January 2018. 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.
- Recalls of fresh produce run a median of 7 months, so this one was shorter than usual for its category. Fresh produce is the category where contamination arrives before the facility does: irrigation water, soil amendments and field workers are the routes, and nothing downstream of the farm is a kill step for a product eaten raw.
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: milk.
Filed under fresh produce and snacks and confectionery. A product can sit in more than one.
Every product in this recall
The FDA opened 5 enforcement records for this one recall, one per product code. This page carries all of them; the 4 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.
Other fresh produce 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 Aurora Products, Inc.
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 18 other records name this firm.
All 19 records for Aurora Products, Inc.
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.