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Organic By Nature, Inc. 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 - F-0975-2021

United States

TerminatedClass I

Company
Organic By Nature, Inc.
Product
Purim Health Products: EpiGenius Kids Creamy Chocolate; 630…
Recall date
May 13, 2021
Terminated
February 18, 2022
Source
FDA

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

  1. - Recall initiated
  2. - Reported by source
  3. - Recall terminated
Recalled products
Product description UPC Quantity Lot / code information
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) Not published in this source record 6398 pouches 74671A, 74671B, 74890A, 74890B, 74891, 75152A, 75152B, 75264A, 75264B, 75265, 75519A, 75519B, 75520, 75852, 75853, 76200, 76457.

Distribution

  • Direct online sales to customers.

Official source record

Agency
FDA
Dataset
FDA Food Enforcement (Recalls)
Recall number
F-0975-2021
Event ID
88513
Status
Terminated
Classification
Class I
Company
Organic By Nature, Inc.
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)
Quantity
6398 pouches
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
Recall initiation date
May 13, 2021
Report date
September 22, 2021
Classification date
Not published in this source record
Termination date
February 18, 2022
Distribution pattern
Direct online sales to customers.
UPC, lot, and code information
74671A, 74671B, 74890A, 74890B, 74891, 75152A, 75152B, 75264A, 75264B, 75265, 75519A, 75519B, 75520, 75852, 75853, 76200, 76457.
Voluntary or mandated
Voluntary: Firm initiated
Initial notification method
Letter
Source last updated
Not tracked separately from the Public Health Trace retrieval date below
Public Health Trace retrieval date

Responsible company: Organic By Nature, Inc.

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Product
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Published
March 2, 2022
Distribution
Direct sales from web site purchases.

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Product
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Published
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Distribution
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Published
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Distribution
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Where this information comes from

View FDA enforcement record -- the specific openFDA record this summary was built from.

This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information. See FDA Enforcement Reports versus recall announcements for how that database differs from a press-release-style announcement.

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Technical source data

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Retrieved by Public Health Trace:

Frequently asked questions

What does a Class I mean?

FDA classifies this recall as Class I. See how to read an FDA recall record (linked above) for what each classification level means.

Is this recall still active?

According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

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Official guidance and record verification

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How to interpret this historical record

This record is preserved as published by FDA, as of February 18, 2022.

Status as reported: Terminated.

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View the official FDA source

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