Drug 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
D-1549-2014
Product summary
- Event
- Event 68638
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,379 bottles
- Official record key
drug-enforcement:D-1549-2014
Official wording
Reason: Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug.
Code information: Lot # 3121005; Exp 02/17
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug.