Wholly Immune Powder, Total Immune Nutrient Support; 300 gram (10.6 oz) and...
FDA Recall #F-1636-2013 — Class II — May 29, 2013
Recall Summary
| Recall Number | F-1636-2013 |
| Date Initiated | May 29, 2013 |
| Classification | Class II |
| Status | Terminated |
| Type | Voluntary: Firm initiated |
| Product Type | Food |
Recalling Firm
| Firm | Allergy Research Group |
| Location | Alameda, CA |
Product Description
Wholly Immune Powder, Total Immune Nutrient Support; 300 gram (10.6 oz) and 900 gram ( 31.7 oz.) containers. Also packaged as Complete Immune Powder and packed in 300 and 900 gram containers. Suggested use: As a dietary supplement, 1 level scoop one or two times daily, mixed with desired liquid or as directed by a healthcare practitioner. California Proposition 65 warning: this product contains lead, a chemical known to the State of California to cause birth defects or other reproductive harm. UCP 13947-73560 and 13947 73820 formulated exclusively for Allergy Research Group, Alameda, CA 94502.
Reason for Recall
Allergy Research Group received word from their contract manufacturer, ABCO Laboratories, that two of their products have been manufactured with soy based products from CHS Inc. at it Ashdod, Israel facility.
Classification
Class II — A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution Pattern
Distributors, Wholesalers, healthcare providers and retail customers in the USA. Nutrilink in England and DeltaStar in the Netherlands are distributors in Europe.
Product Quantity
3000 units of 300 gr powder bottles' 1869 units of 900 gr bottles
Product Codes / Lot Numbers
Product number 73560, 53560 - 300 gr. Lot numbers: 11030685, Exp 6/1/13; 11030686, Exp 6/1/13; 11100829, Exp 11/1/13; 11100835, Exp 11/1/13; 12010362, Exp 4/1/14; 12061214, Exp 8/1/14; 12061217, Exp 8/1/14; 13010635, Exp. 2/1/15. Product number 73820, 53820 - 900 gr. Lot numbers: 11030676, Exp Jun 2013; 11030686, Exp 6/1/13; 11100836, Exp 11/1/13; 12010363, Exp 4/25/14; 12061215, Exp 8/1/14; 12061218, Exp 8/1/14; 13010636, Exp 2/1/15;
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.
In most cases, yes. Retailers are typically notified to accept returns of recalled products and issue refunds, regardless of whether you have a receipt. Check with the store where you purchased the item. Some manufacturers also offer direct refunds — contact the recalling firm using the information in the official recall notice. If you purchased the product online, contact the retailer's customer service with your order number. In either case, you generally do not need original packaging, though retaining the product label with the lot code or UPC can speed up the process.
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.