Doctor's Best Red Yeast Rice Recalled for Undeclared Lovastatin
Doctor's Best is recalling Red Yeast Rice 1200 capsules because FDA analysis found undeclared lovastatin, making it an unapproved new 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 recall is classified as FDA Class II, which corresponds to a 'Severe' severity score under the rubric for significant health risks or regulatory violations involving unapproved drugs.
Plain-English summary
Doctor's Best, Inc. is recalling 7,379 bottles of Doctor's Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottles. The affected product is identified by Lot # 3121005 and an expiration date of 02/17. The product was distributed nationwide.
The recall was initiated because FDA analysis discovered undeclared lovastatin in the product. The presence of this undeclared ingredient means the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), effectively making it an unapproved new drug.
Consumers who have this product should stop using it and contact Doctor's Best, Inc. for further instructions or a refund.
The recalled product
- Product
- Doctor's Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle. UPC 753950001183, Manufactured for Doctor's Best San Clemente, CA 92673
- Manufacturer
- Doctor's Best, Inc.
- Category
- Drug — Dietary Supplement
- Affected units
- 7,379
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 (2)
- Lot # 3121005
- Exp 02/17
Distribution
Distributed nationwide across the United States.
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