Dark Chocolate Covered Almonds 9 oz clam shell & 25 lb box Ingredients: Dark Chocolate…
WHOLE ALTERNATIVES LLC recalled this product and the FDA reported the enforcement action on 14 March 2018 as Class II. The recall was initiated by the firm. The firm was notified by their supplier that they failed to declare milk on the label. Therefore when they repacked the product they did not include milk on their label.
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 Covered Almonds 9 oz clam shell & 25 lb box Ingredients: Dark Chocolate (Sugar, chocolate Liquor, Cocoa Butter, Chocolate Liquor Processed with Alkali, Soy Lecithin (Emulsifier), Salt, Vanilla, Almonds and Confectioners Glaze. Sold under the brand names and Distributed by: Sage Valley St. Augustine, FL 32085-9000 (800) 223-2910 & Tree of Life, LLC, A KeHE Company St. Augustine, FL 32085-9000
- Reason for recall
- The firm was notified by their supplier that they failed to declare milk on the label. Therefore when they repacked the product they did not include milk on their label.
- Recalling firm
- WHOLE ALTERNATIVES LLC
- Firm location
- Louisville, Kentucky, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0920-2018
- Quantity
- 369 cs/12/9 oz clam shells + 20/25 lb boxes
- Distribution
- Product was shipped to the following states: FL, IL, IN, PA & TX
- Initiated
- 31 October 2017
- Reported by FDA
- 14 March 2018
- Terminated
- 9 May 2018
- Firm notified by
- Product codes
- TREE OF LIFE 9 oz, UPC 0 30684 00915 0; LOT 217P10, Best By Date 8/4/2017, LOT 260P08, Best By Date 9/16/2017, LOT 272P08, Best By Date 9/28/2017, LOT 312P09, Best By Date 11/7/2017, LOT 334P11, Best By Date 11/29/2017, LOT 341P15, Best By Date 12/6/2017, LOT 351P16, Best By Date 12/16/2017, LOT 009Q10, Best By Date 1/9/2018 & LOT 114Q04, Best By Date 4/24/2018. SAGE VALLEY 9 oz, UPC 0 30684 01721 6; LOT, 224P06 Best By Date 8/11/2017, LOT, 260P07 Best By Date 9/6/2017, LOT, 315P09 Best By Date 11/10/2017, LOT, 003Q18 Best By Date 1/3/2018, LOT, 020Q15 Best By Date 1/20/2018 & LOT, 076Q18, Best By Date, 3/17/2018. TREE OF LIFE (Bulk), UPC 0 77420 10029 0; LOT CHOCALMD02516314, Best By Date 6/15/2018 & LOT CHOCALMD02517011, Best By Date 6/15/2018
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 record is the only one the FDA opened for its recall event, so it covers a single product code.
- The recall ran for 6 months, from 31 October 2017 to termination on 9 May 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 distribution pattern names 2 states, and the FDA published the enforcement report 4 months after the firm began the recall.
- Recalls of milk or a dairy product run a median of 7 months, so this one was about typical 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: Illinois, Indiana. 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.
Filed under milk and dairy, fish and seafood, nuts and seeds, snacks and confectionery, spices and seasonings and beverages and juice. 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 WHOLE ALTERNATIVES LLC
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2012-12-26 | Dried Apricots 6 oz UPC 7203670494 | Whole Alternatives Llc | Undeclared sulphur dioxide | Class I |
| 2012-12-26 | Dried Golden Raisins 8 oz UPC 7203670490 | Whole Alternatives Llc | Undeclared sulphur dioxide | Class I |
All 3 records for Whole Alternatives Llc
All 2018 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.