XYMOGEN LipiChol (Omega-3 Phospholipid 540 mg) Medical Food Distributed by Xy...

FDA Recall #F-0815-2014 — Class III — August 16, 2013

Recall Summary

Recall NumberF-0815-2014
Date InitiatedAugust 16, 2013
ClassificationClass III
StatusTerminated
TypeVoluntary: Firm initiated
Product TypeFood

Recalling Firm

FirmAtlantic Pro Nutrients, Inc. dba XYMOGEN
LocationOrlando, FL

Product Description

XYMOGEN LipiChol (Omega-3 Phospholipid 540 mg) Medical Food Distributed by Xymogen Orlando, Florida. Also sold and distributed under various brands and firms: *1. 4XLipidComplete (Omega-3 Phospholipid 540 mg) Medical Food Distributed by: N2 Health, La Quinta, CA. *2. AL Metabolic P Manufactured for Integrated Medical Center, Mesa AZ. *3. AstaMega-3 Balance Medical Food Distributed by: Lifestyle Research, Cheyenne, WY. *4.Body Balance H.E.M.M.L.A. Manufactured for: Health Masters, Auburndale, FL. *5. Cardio Protect Manufactured for: Shop The Care Group, LLC, Aurora, CO *6. Cardio-Krill Manufactured for: Whole Health Center, Lone Tree, CO. *7. CardiOmega Distributed by: Vail Valley Pharmacy, Edwards, CO. *8. CholeCare Manufactured for: Dr. Christina M. Tondora Scottsdale, AZ. *9. CHOLESTO-BUST Manufactured for: Clear Sky Medical, Centennial, CO. *10. Manufactured for: Arne Chiropractic & Wellness Center PC, Littleton, CO. *11. Dr. Elkin's CardioBlend Manufactured for: Medical Advocated Inc. Whittier, CA. *12. FaB Fats Manufactured for:Bukovina, Auburn, CA. *13. FEM Lipid Support Manufactured for:FEM Centre, Fort Worth, TX. *14.InflmmaChol Distributed By: INNER SCIENCE, Denver, CO. *15. Integrative Bio-Omega Distributed By: Center for Integrative Bio-Energetics, Santa Monica, CA. *16. ItisControl Distributed By: The 2nd Opinion Inc.Chattanooga, OK. *17. Killer Krill Manufactured for: Integrated Medical Care, Littleton, CO. *18. 360 Medicine Krill Pills Manufactured for: Russ Canfield, MD Santa Fe, NM. *19. Krill Supreme Manufactured for: Health Bridge, Great Neck, NY. *20. Krill-Xanthin Manufactured for: Envita Lifestyle, Scottsdale, AZ. *21. " Li-Chol Manufactured for: Pierce Integrative Medical Center, West Bloomfield, MI. *22. Antarctic Omega Cholesterol Free Distributed By: Villa Park Medical , Villa Park, CA. *23.Lipechol Manufactured For: Women's View Medical Group Holistic Center for Integrated Family Health Care, Upland, CA. *24. Lipical Manufactured For: Ruben Ruiz, M.D.,Montebello, CA. *25. Lipicare Manufactured For: Center for Optimum Health, Los Angeles, CA. *26. Lipichol Krill Mfd for: Longevity Orthopedic Center Inc., Mission Viejo, CA. *27. Lipicontrol Distributed By: Dr. Robert Derryberry, D.C., Paso Robles, CA. *28. " Lipid Complete 360 More than a Fish Oil Distributed By: Pure Biotics, LLC, Tustin, CA. *29. Lipid Balance Food Formulated for: Uzzi Reiss, M.D., Beverly Hills, CA. *30. Lipid Complete Distributed By: Advanced Integrative Medicine, Park Meadows Drive, CO. *31. Lipid Support Distributed By: Rehabilitation Chiropractic Care, Mesa, AZ. *32.Lipid ProtX Manufactured For: Inspire, San Diego, CA. *33. LipiKol Manufactured For: Karima Hirani, M.D., MPH, Hirani Wellness Medical Center, Inc. Culver City, CA. *34. LipiKrill Distributed By: Advance Body Dynamics, Centennial, CO. *35. LipidControl Distributed By: Center for Integrative Medicine, Valley Springs, CA. *36. LipidChol Distributed By: Body Hormone Balance, Texarkana, TX. *37. Lipid ProtX Manufactured For: Premier Health and Wellness Screven Edgerton, M.D., Austin, TX. *38. Marine Lipids EPA-DHA Manufactured For: Dr. Cochrans's Nutraceuticals, Tucson, AZ. *39. Omega Antarctica Manufactured For: Mohammed Ali, M.D. Health & Wellness Center, Inc., Lake Forest, CA. *40. Omega Antarctica Manufactured For: Mohammed Ali, M.D. Health & Wellness Center, Inc., San Clemenete, CA. *41. Lipochol Manufactured For: Phillips Clinic, Las Vegas, NV. *42. LipiKrill Manufactured For: Quest for Wellness, Payson, AZ. *43. LipiXanthin-EX Manufactured For: Health Tools LLC, Clarksville, TN. *44. OmegaPhos Distributed By: Therapeutic Lifestyle Center, Idyllwild, CA. *45. Omega Strength Distributed By: Healthy Cells Wellness, Windermere, FL. *46. OmegaPhos Manufactured For: Dr. Chris Fiorentino, Santa Ana, CA. *47. Omega Supreme Krill Manufactured For: NutriMedical Inc., Vista, CA. *48. OmegaXan Krill Oil Distributed By: True Wellness LLC, Austin, TX. *49. Phospholopid

Reason for Recall

Product was labeled as a medical food as opposed to a dietary supplement.

Classification

Class III — A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

Distribution Pattern

Nationwide and Alaska Canada and China

Product Quantity

25,852 bottles (All brands)

Product Codes / Lot Numbers

UPC # 8 71149 00375 3 and UPC # 8 71149 00891 8 Lot # 50001784 exp. 09/2014, lot # 50001783 exp. 09/2014, lot # 50002588 exp 11/2015, and lot # 50002587 exp. 11/2015

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.