FDA recall D-1549-2014

Doctor's Best, Inc. · Class II · 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

Reason for recall

Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2014-06-24
Report date
2014-08-27
Termination date
2014-10-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Clemente, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1549-2014