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Class III: unlikely to cause harmTerminated

Atlantic Pro Nutrients, Inc. dba XYMOGEN XYMOGEN LipiChol Recall

XYMOGEN LipiChol (Omega-3 Phospholipid 540 mg) Medical Food Distributed by Xymogen Orla…

Atlantic Pro Nutrients, Inc. dba XYMOGEN · Orlando, FL

Risk level
Class III
Reported by FDA
Jan 8, 2014
Recall ID
F-0815-2014
Check your lot numberHow we source this data

Summary

Atlantic Pro Nutrients, Inc. dba XYMOGEN recalled XYMOGEN LipiChol starting Aug 16, 2013. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report F-0815-2014 on Jan 8, 2014. Reason: Product was labeled as a medical food as opposed to a dietary supplement. Status: Terminated.

Why it was recalled

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

Lot numbers, UPCs & expiration 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

Where it was sold

Nationwide and Alaska Canada and China

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-0815-2014
Classification
Class III
Status
Terminated
Recall initiated
Aug 16, 2013
FDA report date
Jan 8, 2014
Quantity
25,852 bottles (All brands)
Recall type
Voluntary: Firm initiated
Recalling firm
Atlantic Pro Nutrients, Inc. dba XYMOGEN

Original FDA data

Every field from FDA enforcement report F-0815-2014, exactly as published.

Show all FDA fields
City
Orlando
State
FL
Status
Terminated
Country
United States
Event ID
66135
Address
6900 Kingspointe Pkwy
Code information
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
Postal code
32819-6544
Report date
Jan 8, 2014
Product type
Food
Recall number
F-0815-2014
Classification
Class III
Recalling firm
Atlantic Pro Nutrients, Inc. dba XYMOGEN
Product quantity
25,852 bottles (All brands)
Termination date
May 2, 2014
Reason for recall
Product was labeled as a medical food as opposed to a dietary supplement.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide and Alaska Canada and China
Recall initiation date
Aug 16, 2013
Initial firm notification
E-Mail
Center classification date
Dec 30, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-0815-2014, published Jan 8, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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