Atlantic Pro Nutrients, Inc. dba XYMOGEN recall: XYMOGEN LipiChol (Omega-3 Phospholipid 540 mg) Medical Food Distributed by Xymogen Orlando, Florida

The recall

Company

Atlantic Pro Nutrients, Inc. dba XYMOGEN (Orlando, FL)

Reason, in FDA's words

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

Where it was sold

Nationwide and Alaska Canada and China

Recall began

August 16, 2013, by the company

FDA classified it

December 30, 2013

First in an FDA Enforcement Report

January 8, 2014

FDA event number

66135

The 2 products recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

• F-0815-2014 Class III

  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

  Codes: 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

  Quantity: 25,852 bottles (All brands)

• F-0816-2014 Class III

  LipiChol 540 (Omega-3 Phospholipid) Medical Food Dispense by Prescription Distributed by: PharmaceutiX Orlando, Florida

  Codes: UPC # N3 53731-001-06 9 Lot # 50001784 exp. 09/2014, lot # 50001783 exp. 09/2014, lot # 50002588 exp 11/2015, and lot # 50002587 exp. 11/2015

  Quantity: 25,852 bottles (All Brands)

Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of January 8, 2014.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.