Reported May 28, 2014 · Terminated

Red Yeast Rice High Potency Dietary Supplement, 600 mg, packaged in a) 120-count VegeCaps per bottle (UPC 8 01650 02205…

Independent Nutrition Center, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Independent Nutrition Center, Inc. · 4091 W 11th Ave Ste C · Eugene, OR · 97402-5602

Is this the product you have?

3 of 3 products

Products covered by this recall
#Product as published
1120-count VegeCaps per bottle (UPC 8 01650 02205
2and
3500-count VegeCaps per bottle (UPC 8 01650 02206 6), Manufactured by: Back to Health, Eugene, Oregon 97402.
Lot codes and dates
    • Lot #: 1402009
    • 1312008
    • 1309017
    • and 1308009
Amount recalled
a) 209 bottles and b) 8 bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 24, 2014 · Data as of Sep 19, 6:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.