# FDA recall D-1549-2014

> **Doctor's Best, Inc.** · Class II · drug recall initiated 2014-06-24.

## 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

- **Recall number:** D-1549-2014
- **Recalling firm:** Doctor's Best, Inc.
- **Classification:** Class II
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-1549-2014. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1549-2014. Source: US FDA. Licensed CC0.

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