drugs Class II Updated 2014-05-28

Independent Nutrition Center, Inc. recalls Red Yeast Rice High Potency Dietary Supplement, 600 mg, pack

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 1402009; 1312008; 1309017; and 1308009
View official government recall

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