Red Yeast Rice Supplement Recalled for Excessive Lovastatin Levels
Independent Nutrition Center is recalling Red Yeast Rice High Potency Dietary Supplement because it contains excessive levels of lovastatin, an FDA-approved drug.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the product contains excessive levels of an unapproved drug (lovastatin), which fits the criteria for a Severe recall involving significant health risks.
Plain-English summary
Independent Nutrition Center, Inc. is recalling Red Yeast Rice High Potency Dietary Supplement, 600 mg. The product is packaged in 120-count and 500-count VegeCaps per bottle. The recall involves 209 bottles of the 120-count size and 8 bottles of the 500-count size.
The recall is being conducted because the product contains excessive levels of lovastatin. Lovastatin is an FDA-approved drug, which makes this dietary supplement an unapproved new drug. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The affected product was distributed nationwide and in Puerto Rico. The specific lot numbers involved are 1402009, 1312008, 1309017, and 1308009. Consumers should check their inventory for these lot numbers and stop using the product if it matches the description.
The recalled product
- 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.
- Manufacturer
- Independent Nutrition Center, Inc.
- Category
- Drug — Dietary Supplement
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 1402009
- 1312008
- 1309017
- and 1308009
Distribution
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