Class IF-0975-2021

Class I— FDA's most serious classification, issued when there is a reasonable probability that consumption of or exposure to the product will cause serious adverse health consequences or death.

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)

Type: Food
Affected lot / code info: 74671A, 74671B, 74890A, 74890B, 74891, 75152A, 75152B, 75264A, 75264B, 75265, 75519A, 75519B, 75520, 75852, 75853, 76200, 76457.
Quantity: 6398 pouches

Why it was recalled

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

Firm: Organic By Nature, Inc.
Notification channel: Letter
Type: Voluntary: Firm initiated
Address: 2610 Homestead Pl, N/A, Rancho Dominguez, California 90220-5610

Distribution

Distribution pattern: Direct online sales to customers.

Timeline

Recall initiated: 2021-05-13
FDA classified: 2021-09-13
Posted by FDA: 2021-09-22
Terminated: 2022-02-18
Status: Terminated

Source: openFDA Food Enforcement endpoint. Recall record F-0975-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings.