FDA recall D-1349-2014

Independent Nutrition Center, Inc. · Class II · 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.

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.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2014-04-29
Report date: 2014-05-28
Termination date: 2014-07-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Eugene, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1349-2014