RecallHawk
Class I Recall

Purim Health Products: EpiGenius Kids Creamy Chocolate; 630 Grams, individually packed pouches. Daily Superfoods. Th

Organic By Nature, Inc.

Summary

The FDA issued a Class I for Purim Health Products: EpiGenius Kids Creamy Chocolate; 630 Grams, individually by Organic By Nature, Inc.. Reason: 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.

Details

Source

Food Recall

External ID

F-0975-2021

Action Date

2021-09-22

Status

Terminated

Category

food

Product Description

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)

Lot/Code Info: 74671A, 74671B, 74890A, 74890B, 74891, 75152A, 75152B, 75264A, 75264B, 75265, 75519A, 75519B, 75520, 75852, 75853, 76200, 76457.

Quantity Affected: 6398 pouches

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

Distribution

Direct online sales to customers.

Type: Voluntary: Firm initiated

Recall Initiated: 2021-05-13

Company

Organic By Nature, Inc.

Rancho Dominguez, CA

Context & Analysis

This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.

This was one of 30 food recalls issued in the same week, part of 204 food-related FDA actions this month.

Organic By Nature, Inc. has 2 FDA actions in our database, including 2 recalls.

Frequently Asked Questions

What is a Class I recall?

A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Organic By Nature, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Organic By Nature, Inc. have FDA actions?

Organic By Nature, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "F-0975-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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