Key Takeaway

LipiChol 540 (Omega-3 Phospholipid) Medical Food Dispense by Prescription Distributed by: PharmaceutiX Orlando, Florida by Atlantic Pro Nutrients, Inc. dba XYMOGEN was recalled on August 16, 2013. The hazard: Product was labeled as a medical food as opposed to a dietary supplement.

FDA Food Class III Terminated

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

Recalled: August 16, 2013 ~25,852 bottles (All Brands) units affected F-0816-2014

Description

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

Hazard / Reason

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

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

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

Food

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

Food

Company Information

Atlantic Pro Nutrients, Inc. dba XYMOGEN

Orlando, FL, United States

View all 3 recalls by Atlantic Pro Nutrients, Inc. dba XYMOGEN →

Distribution

Nationwide and Alaska Canada and China

Related Recalls

Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Food. Visit the agency's official website for the original notice.

Data sourced from FDA Food Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.