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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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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

Product Detail

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