Home / Recalls / Independent Nutrition Center, Inc. / D-1349-2014

D-1349-2014 Class II Terminated

Recalled by Independent Nutrition Center, Inc. — Eugene, OR

Recall Details

Product Type: Drugs
Report Date: May 28, 2014
Initiation Date: April 29, 2014
Termination Date: July 24, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: a) 209 bottles and b) 8 bottles

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot #: 1402009; 1312008; 1309017; and 1308009