Drug product
Red Yeast Rice High Potency Dietary Supplement, 600 mg, packaged in a) 120-count VegeCaps per bottle (UPC 8 01650 02205 9) and b) 500-count VegeCaps per bottle (UPC 8 01650 02206 6), Manufactured by: Back to Health, Eugene, Oregon 97402.
D-1349-2014
Product summary
- Event
- Event 68199
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 209 bottles and b) 8 bottles
- Official record key
drug-enforcement:D-1349-2014
Official wording
Reason: Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Lovastatin is an FDA approved drug making this dietary supplement an unapproved new drug.
Code information: Lot #: 1402009; 1312008; 1309017; and 1308009
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Unknown
Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Lovastatin is an FDA approved drug making this dietary supplement an unapproved new drug.