Purim Health Products: EpiGenius Kids Creamy Chocolate; 630 Grams, individually packed…
Organic By Nature, Inc. recalled this product and the FDA reported the enforcement action on 22 September 2021 as Class I. The recall was initiated by the firm. Product recalled due to undeclared milk in MCT powder used in manufacturing. Milk is not declared on the label. Product item #'s 4600-P65, 4600
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 Products: EpiGenius Kids Creamy Chocolate; 630 Grams, individually packed pouches. Daily Superfoods. This high protein, whole-food blend is an excellent source of vitamins A, C, D and E and contains superfruits and superveggies, along with healthy fat, fiber and probiotics. UPC: 7 64934 04600 7 Distributed by Purim, 2610 Homestead Place, Rancho Dominguez, CA Mix approximately 3 tablespoons with 8-10 oz. of cold water. i. MCT powder as a whole is 6% of the formula (37.8g) ii. The ingredient within the MCT powder (tapioca starch) that was listed as the source of the contamination from Nutralliance, is calculated at 2.9095% of the formula (18.3g)
- UPC
- 764934046007
- Reason for recall
- Product recalled due to undeclared milk in MCT powder used in manufacturing. Milk is not declared on the label. Product item #'s 4600-P65, 4600
- Recalling firm
- Organic By Nature, Inc.
- Firm location
- Rancho Dominguez, California, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-0975-2021
- Quantity
- 6398 pouches
- Distribution
- Direct online sales to customers.
- Initiated
- 13 May 2021
- Reported by FDA
- 22 September 2021
- Terminated
- 18 February 2022
- Firm notified by
- Letter
- Product codes
- 74671A, 74671B, 74890A, 74890B, 74891, 75152A, 75152B, 75264A, 75264B, 75265, 75519A, 75519B, 75520, 75852, 75853, 76200, 76457.
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 9 months, from 13 May 2021 to termination on 18 February 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 4 months after the firm began the recall.
- Recalls of a dietary supplement run a median of 15 months, so this one was shorter than usual for its category. Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.
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 dietary supplements and snacks and confectionery. A product can sit in more than one.
Other dietary supplements 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 2021 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.