Why it was recalled
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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 1402009; 1312008; 1309017; and 1308009
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1349-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 29, 2014
- FDA report date
- May 28, 2014
- Quantity
- a) 209 bottles and b) 8 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Independent Nutrition Center, Inc.
Original FDA data
Every field from FDA enforcement report D-1349-2014, exactly as published.
Show all FDA fields
- City
- Eugene
- State
- OR
- Status
- Terminated
- Country
- United States
- Event ID
- 68199
- Address
- 4091 W 11th Ave Ste C
- Code information
- Lot #: 1402009; 1312008; 1309017; and 1308009
- Postal code
- 97402-5602
- Report date
- May 28, 2014
- Product type
- Drugs
- Recall number
- D-1349-2014
- Classification
- Class II
- Recalling firm
- Independent Nutrition Center, Inc.
- Product quantity
- a) 209 bottles and b) 8 bottles
- Termination date
- Jul 24, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Apr 29, 2014
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 22, 2014