FDA-Drug2014-05-28Class II
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.
Independent Nutrition Center, Inc.
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.
Sold states
Nationwide and Puerto Rico
Affected count
a) 209 bottles and b) 8 bottles
Manufactured in
4091 W 11th Ave Ste C, N/A, Eugene, OR, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1349-2014Don't want to check this manually?
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