FDA Drug recall D-1349-2014
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…
- FDA Drug
- Class II
- terminated
- Published 2014-05-28
On 2014-05-28 the FDA classified a Class II recall of 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… by Independent Nutrition Center, citing 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 unappr….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1349-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-29 |
| Published | 2014-05-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Independent Nutrition Center |
| Distribution | US |
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
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.
Identifiers
| upc | 801650022059 |
|---|---|
| upc | 801650022066 |
| code_info | Lot #: 1402009; 1312008; 1309017; and 1308009 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1349-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.