Independent Nutrition Center, Inc. recalls Red Yeast Rice High Potency Dietary Supplement, 600 mg, packaged in a) 120-count VegeCaps per bottle (UPC 8 01650 02205
Recalled May 28, 2014 · FDA recall D-1349-2014 · Independent Nutrition Center
Hazard
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. · FDA Class II
Units
a) 209 bottles and b) 8 bottles
Sold at
Nationwide and Puerto Rico
Description
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.
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.
Manufacturer(s)
Independent Nutrition Center, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →