Purim Health Products: EpiGenius Kids Creamy Chocolate; 630 Grams, individua...
FDA Recall #F-0975-2021 — Class I — May 13, 2021
Recall Summary
| Recall Number | F-0975-2021 |
| Date Initiated | May 13, 2021 |
| Classification | Class I |
| Status | Terminated |
| Type | Voluntary: Firm initiated |
| Product Type | Food |
Recalling Firm
| Firm | Organic By Nature, Inc. |
| Location | Rancho Dominguez, CA |
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)
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
Classification
Class I — A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Distribution Pattern
Direct online sales to customers.
Product Quantity
6398 pouches
Product Codes / Lot Numbers
74671A, 74671B, 74890A, 74890B, 74891, 75152A, 75152B, 75264A, 75264B, 75265, 75519A, 75519B, 75520, 75852, 75853, 76200, 76457.
What Should You Do?
Stop consuming this product immediately. Check your home for the recalled item and dispose of it safely. If you experienced a health issue after consuming this product, contact your doctor and report it to the FDA MedWatch.
Frequently Asked Questions
Stop consuming the product immediately and do not donate or give it to others. Check the recall notice above for specific disposal or return instructions. Many food recalls ask you to throw the product away and retain the packaging for a possible refund from the retailer. If you purchased it online, check your order history — some retailers send recall notifications directly to customers. You do not need a receipt to report an issue or seek a refund; the fact of purchase is typically sufficient.
If you have a food allergy and consumed the recalled product, monitor yourself closely for allergic reaction symptoms — including hives, swelling, difficulty breathing, nausea, vomiting, or anaphylaxis. If you experience any symptoms, seek medical attention immediately. For anaphylaxis (severe allergic reaction with difficulty breathing, rapid heartbeat, or loss of consciousness), call 911 and use an epinephrine auto-injector (EpiPen) if available. Stop consuming the product and check all products from the same manufacturer for similar labeling issues, as undeclared allergens sometimes affect multiple products from the same production facility.
Report foodborne illnesses and adverse food reactions to the FDA through the MedWatch Safety Reporting Portal at FDA.gov, or by calling 1-800-332-1088. You can also report issues directly to the FDA's Safety Reporting Portal at SafetyReporting.hhs.gov. If you believe there is an immediate public health risk, contact your local health department. Your report helps the FDA identify contamination patterns, initiate recalls faster, and protect other consumers from the same hazard. Include as much detail as possible: the product name, lot code, purchase date and location, and a description of your symptoms or findings.
The FDA assigns a status to each recall action throughout its lifecycle. "Ongoing" means the recall is active — the firm is still working to remove the product from commerce and notify consumers. "Completed" means the recall strategy has been implemented and the FDA has determined that the recalling firm has taken all appropriate steps to remove the product. "Terminated" means the FDA has reviewed the results and concluded the recall is complete. Even if a recall is marked as completed or terminated, you should still discard any recalled products you find at home — the recall status refers to the firm's compliance actions, not the safety of product still in consumers' possession.