Why it was recalled
Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug.
Product description
Doctor's Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle. UPC 753950001183, Manufactured for Doctor's Best San Clemente, CA 92673
Lot numbers, UPCs & expiration codes
Lot # 3121005; Exp 02/17
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1549-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 24, 2014
- FDA report date
- Aug 27, 2014
- Quantity
- 7,379 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Doctor's Best, Inc.
Original FDA data
Every field from FDA enforcement report D-1549-2014, exactly as published.
Show all FDA fields
- City
- San Clemente
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 68638
- Address
- 197 Avenida La Pata
- Code information
- Lot # 3121005; Exp 02/17
- Postal code
- 92673-6307
- Report date
- Aug 27, 2014
- Product type
- Drugs
- Recall number
- D-1549-2014
- Classification
- Class II
- Recalling firm
- Doctor's Best, Inc.
- Product quantity
- 7,379 bottles
- Termination date
- Oct 21, 2014
- Reason for recall
- Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Doctor's Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle. UPC 753950001183, Manufactured for Doctor's Best San Clemente, CA 92673
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 24, 2014
- Initial firm notification
- Press Release
- Center classification date
- Aug 20, 2014