Sea Salt Caramels Tumbled In Milk Chocolate, Moonstruck brand. The product sold in an…
Moonstruck Chocolate Company recalled this product and the FDA reported the enforcement action on 2 January 2019 as Class I. The recall was initiated by the firm. The Sea Salt Caramels Tumbled In Milk Chocolate is recalled due to a potential to be contaminated with hazelnuts and the finished label does not declare hazelnuts.
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
- Sea Salt Caramels Tumbled In Milk Chocolate, Moonstruck brand. The product sold in an individual resealable plastic bag, net wt. 4 oz. The product is number is 312235 and the UPC code is 7 11175 12235 9. The product also sold in cardboard box of 8/4 oz. bags. The box has the SKU number 312235 and the UPC code 10711175122356.
- Reason for recall
- The Sea Salt Caramels Tumbled In Milk Chocolate is recalled due to a potential to be contaminated with hazelnuts and the finished label does not declare hazelnuts.
- Recalling firm
- Moonstruck Chocolate Company
- Firm location
- Portland, Oregon, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-0752-2019
- Quantity
- 600/4 oz. bags
- Distribution
- distributed in AZ, CA, ID, NH, NY, OR, TX, and WA.
- Initiated
- 11 December 2018
- Reported by FDA
- 2 January 2019
- Terminated
- 5 February 2019
- Firm notified by
- Press Release
- Product codes
- Best By: 11/12/2019 and 11/13/2019. Lot numbers: 1094276 and 1094275.
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 8 weeks, from 11 December 2018 to termination on 5 February 2019. 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 7 states, and the FDA published the enforcement report 3 weeks after the firm began the recall.
- Recalls of milk or a dairy product run a median of 7 months, so this one was shorter 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.
Named in the distribution pattern: California, Idaho, New Hampshire, New York, Oregon, Texas, Washington. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.
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, tree nuts.
Filed under milk and dairy, snacks and confectionery and spices and seasonings. A product can sit in more than one.
Other milk and dairy 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 Moonstruck Chocolate Company
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
All 4 records for Moonstruck Chocolate Company
All 2019 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.