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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

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.
Recall Number D-1349-2014
Classification Class II
Code Info Lot #: 1402009; 1312008; 1309017; and 1308009
Product Distributed Qty a) 209 bottles and b) 8 bottles
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.

Event Detail

Event Id 68199
Product Type Drugs
Status Ongoing
Recalling Firm Independent Nutrition Center, Inc.
City Eugene
State OR
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-29
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide and Puerto Rico