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Recall Observatory FDA recall evidence

Drug product

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.

D-1349-2014

April 29, 2014

Class II

Product summary

Firm
Independent Nutrition Center, Inc.
Event
Event 68199
Status
Terminated
Classification
Class II
Quantity
a) 209 bottles and b) 8 bottles
Official record key
drug-enforcement:D-1349-2014

Official wording

Reason: 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.

Code information: Lot #: 1402009; 1312008; 1309017; and 1308009

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.