Drug recall
Sunburst CHOLESTRIX Red Rice Yeast Extract, Standardized to contain 1.35% Lovastatin, A Dietary Supplement, 90…
FDA recall event 45490 · Class II · Sunburst Biorganics Inc.
Key facts
| Event ID | 45490 |
|---|---|
| Recall numbers | D-033-2008 |
| Recalling firm | Sunburst Biorganics Inc. |
| Product type | Drugs |
| Products | Sunburst CHOLESTRIX Red Rice Yeast Extract, Standardized to contain 1.35% Lovastatin, A Dietary Supplement, 90 Vegetable Capsules, Distributed by SUNBURST BIORGANICS, Baldwin, NY 11510, Product #489… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Unapproved new drug marketed without an approved NDA/ANDA containing Lovastatin, the active pharmaceutical ingredient in Mevacor. |
| Initiation date | Aug 14, 2007 |
| Termination date | Nov 30, 2007 |
| City | Baldwin |
| State | NY |
| Country | United States |
| FEI number | 3005139636 |
At a glance
- 1–9 Products in this recall
- 1–9 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