Purim Health Brands EpiGenius Kids Chocolate: Daily Superfood 630 g pouches Suggested…
Organic By Nature, Inc. recalled this product and the FDA reported the enforcement action on 2 March 2022 as Class II. The recall was initiated by the firm. MCT 50% powder ingredient used in production was recalled due to 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
- Purim Health Brands EpiGenius Kids Chocolate: Daily Superfood 630 g pouches Suggested Use: Mix approximately three tablespoons with 8-10 ounces of cold water. Shake vigorously or blend. For a creamier texture, mix with your favorite non-diary milk or in smoothie. This delicious rich chocolate shake can be enjoyed any time of day, as a stand alone or as a complement to any meal. Ingredients: Proprietary Organic Vegan Protein Blend (Organic Pea Protein, Organic Hemp Protein), Proprietary Organic Anti-Oxidant Fruit & Berry Blend (Organic Apple, Organic Acerola Extract, Organic Acai, Organic Amla, Organic Black Currant, Organic Blackberry, Organic Blueberry, Organic Lemon Juice Powder, Organic Maqui Berry, Organic Pomegranate Juice Powder , Organic Raspberry, Organic Strawberry, Organic Tart Cherry), Proprietary Functional Fat Blend (Medium Chain Triglycerides Oil, Natural Vitamin E from Sunflower Oil Powder), Proprietary Algae Blend (Organic Spirulina, Organic Chlorella, Algal D (Vegan Vitamin D3)), Organic Guar Gum Soluble Fiber, Proprietary Biome Medic" Gut Health Blend (Digestive Wheat Germ Extract Powder, Chicory Root Fiber Extract, Fulvic & Humic Acid Blend, Lactospore¿ (Bacillus coagulans 225 million CFU)), Proprietary Organic Vegetable Blend (Organic Broccoli, Organic Cabbage, Organic Carrot, Organic Kale, Organic Parsley, Organic Spinach, Organic Sweet Potato), Digezyme¿ Enzyme Blend (¿-amylase, protease, cellulase, lactase, lipase), Organic Fair Trade Cocoa Powder, Organic Flavoring, Organic Luo Han Guo Berry (Monk Fruit) Extract, Himalayan Pink Salt. DigeZyme¿ and Lactospore¿ are registered trademarks of Sabinsa Corp. Product numbers 4600 and 4600-P65
- Reason for recall
- MCT 50% powder ingredient used in production was recalled due to undeclared milk.
- Recalling firm
- Organic By Nature, Inc.
- Firm location
- Rancho Dominguez, California, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0740-2022
- Quantity
- 6080 pouches
- Distribution
- Direct sales from web site purchases.
- Initiated
- 31 December 2021
- Reported by FDA
- 2 March 2022
- Terminated
- 10 May 2022
- Firm notified by
- Product codes
- Product # 4600 - lot#: 72630B, 72683B, 72809, 72810B,72811B, 72832B, 73453B, 72831, 73892B, 74115B, 74182B, 74508B. Product # 4600-P65: Lot #'s: 72630A, 72630A, 72810A, 72811A, 72832A, 73453A, 73892A, 73892A, 74182A, 74508A.
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 4 months, from 31 December 2021 to termination on 10 May 2022. 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 2 months 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.
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, fresh produce, dietary supplements, snacks and confectionery, spices and seasonings, grains, flour and pasta, beverages and juice and prepared meals and sandwiches. 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 Organic By Nature, Inc.
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 15 other records name this firm.
All 16 records for Organic By Nature, Inc.
All 2022 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.