FDAFDA · Food and drugs·Recall number D-1349-2014
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.
Published May 28, 2014 · Recall initiated: April 29, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Independent Nutrition Center, Inc.
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot #: 1402009; 1312008; 1309017; and 1308009
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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