Ortho Molecular Products LifeCORE Complete, Rich Dark Chocolate, Dietary Supp...

FDA Recall #F-2414-2014 — Class I — August 1, 2014

Recall Summary

Recall NumberF-2414-2014
Date InitiatedAugust 1, 2014
ClassificationClass I
StatusTerminated
TypeVoluntary: Firm initiated
Product TypeFood

Recalling Firm

FirmOrtho Molecular Products Inc
LocationStevens Point, WI

Product Description

Ortho Molecular Products LifeCORE Complete, Rich Dark Chocolate, Dietary Supplement, Sold in the following size containers: 1. Net Wt. 32.6 Grams (1.2Oz), Product #929032, UPC 15033-01929; 2. Net Wt. 911.4 Grams (32.1oz), Product #929001, UPC 15033-00929.

Reason for Recall

Ortho Molecular Products is recalling all lots of LifeCore Chocolate and LifeCore Complete Chocolate because the flavoring may contain undeclared milk.

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

nationwide OUS to China

Product Quantity

19,288 units total

Product Codes / Lot Numbers

Lot numbers beginning with the following numbers: 73286, 73288, 73455, 73482, 73569, 73620, 73840, 73859, 73987, 74038, 74419, 74562, 74773, 74920, 75309, 75339, 75568, 75749, 75919. Expiration dates: Feb-13 thru Apr-15 Lot number and expiration date can be located at the neck of the bottle just above the label.

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.