Drug recall
Doctor' s Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle. UPC 753950001183, Manufactured for…
FDA recall event 68638 · Class II · Doctor's Best, Inc.
Key facts
| Event ID | 68638 |
|---|---|
| Recall numbers | D-1549-2014 |
| Recalling firm | Doctor's Best, Inc. |
| Product type | Drugs |
| Products | Doctor' s Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle. UPC 753950001183, Manufactured for Doctor's Best San Clemente, CA 92673 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug. |
| Initiation date | Jun 24, 2014 |
| Report date | Aug 27, 2014 |
| Termination date | Oct 21, 2014 |
| City | San Clemente |
| State | CA |
| Country | United States |
| FEI number | 3008986770 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: