Red Yeast Rice High Potency Dietary Supplement recall
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.
Why was Red Yeast Rice High Potency Dietary Supplement 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 1402009; 1312008; 1309017; and 1308009
- 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.
- Recalling firm
- Independent Nutrition Center, Inc.
- Quantity
- a) 209 bottles and b) 8 bottles
- Distribution
- Nationwide and Puerto Rico
- Recall date
- May 28, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)