Drug recall
Red Yeast Rice High Potency Dietary Supplement, 600 mg, packaged in a) 120-count VegeCaps per bottle (UPC 8…
FDA recall event 68199 · Class II · Independent Nutrition Center, Inc.
Key facts
| Event ID | 68199 |
|---|---|
| Recall numbers | D-1349-2014 |
| Recalling firm | Independent Nutrition Center, Inc. |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Apr 29, 2014 |
| Report date | May 28, 2014 |
| Termination date | Jul 24, 2014 |
| City | Eugene |
| State | OR |
| Country | United States |
| FEI number | 3004866493 |
At a glance
- 1–9 Products in this recall
- 10–99 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: