# FDA recall D-1349-2014

> **Independent Nutrition Center, Inc.** · Class II · drug recall initiated 2014-04-29.

## Product

Red Yeast Rice High Potency Dietary Supplement, 600 mg, packaged in a) 120-count VegeCaps per bottle (UPC 8 01650 02205 9) and b) 500-count VegeCaps per bottle (UPC 8 01650 02206 6), Manufactured by: Back to Health, Eugene, Oregon 97402.

## Reason for recall

Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Lovastatin is an FDA approved drug making this dietary supplement an unapproved new drug.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1349-2014
- **Recalling firm:** Independent Nutrition Center, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-04-29
- **Report date:** 2014-05-28
- **Termination date:** 2014-07-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Eugene, OR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1349-2014

## Citation

> AI Analytics. FDA recall D-1349-2014. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/D-1349-2014. Source: US FDA. Licensed CC0.

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