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Class III: unlikely to cause harmTerminated

Atlantic Pro Nutrients, Inc. dba XYMOGEN LipiChol 540 Recall

LipiChol 540 (Omega-3 Phospholipid) Medical Food Dispense by Prescription Distributed b…

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

Risk level
Class III
Reported by FDA
Jan 8, 2014
Recall ID
F-0816-2014
Check your lot numberHow we source this data

Summary

Atlantic Pro Nutrients, Inc. dba XYMOGEN recalled LipiChol 540 starting Aug 16, 2013. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report F-0816-2014 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

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

Lot numbers, UPCs & expiration 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

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-0816-2014
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-0816-2014, 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 # 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
Postal code
32819-6544
Report date
Jan 8, 2014
Product type
Food
Recall number
F-0816-2014
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
LipiChol 540 (Omega-3 Phospholipid) Medical Food Dispense by Prescription Distributed by: PharmaceutiX Orlando, Florida
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-0816-2014, published Jan 8, 2014. View the source record (openFDA) · FDA enforcement reports

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

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