D-1549-2014 Class II Terminated
FDA drug recall D-1549-2014 was initiated by Doctor's Best, Inc. on June 24, 2014 and is designated Class II. Reason for recall: Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug. The recall status is terminated (terminated October 21, 2014). Affected quantity: 7,379 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 27, 2014
- Initiation Date
- June 24, 2014
- Termination Date
- October 21, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,379 bottles
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
Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug.
Distribution Pattern
Nationwide
Code Information
Lot # 3121005; Exp 02/17