Recall Number: F-0815-2014

City: Orlando

State: Florida

Country: United States

Classification: Class III

Classification Date: 2013-12-30

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

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

Report Date: 2014-01-08

Product Type: Food

Company: Atlantic Pro Nutrients, Inc. dba XYMOGEN

Status: Terminated

Recall Number: F-0815-2014

Postal Code: 32819-6544

Recall Initiation Date: 2013-08-16

Recall End Date: 2014-05-02

Event ID: 66135

Distribution Pattern: Nationwide and Alaska Canada and China

Voluntary Or Mandated: Voluntary: Firm initiated

Initial Firm Notification: E-Mail

Extra Info: 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

Product Quantity: 25,852 bottles (All brands)

Address: 6900 Kingspointe Pkwy