Why it was recalled
Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.
Product description
THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Count Bottles, THINOGENICS LLC, Nashville, TN 37203 USA.
Lot numbers, UPCs & expiration codes
None Available. All lots distributed prior to 02/06/2014 are being recalled.
Where it was sold
U.S. Nationwide and Canada
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-1594-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 9, 2014
- FDA report date
- Sep 24, 2014
- Quantity
- Unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nature's Universe
Original FDA data
Every field from FDA enforcement report D-1594-2014, exactly as published.
Show all FDA fields
- City
- Nashville
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 68455
- Address
- 2817 West End ave.
- Code information
- None Available. All lots distributed prior to 02/06/2014 are being recalled.
- Postal code
- 37203-1453
- Report date
- Sep 24, 2014
- Product type
- Drugs
- Recall number
- D-1594-2014
- Classification
- Class I
- Recalling firm
- Nature's Universe
- Product quantity
- Unknown
- Termination date
- Apr 10, 2015
- Reason for recall
- Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Count Bottles, THINOGENICS LLC, Nashville, TN 37203 USA.
- Distribution pattern
- U.S. Nationwide and Canada
- Recall initiation date
- Apr 9, 2014
- Initial firm notification
- Press Release
- Center classification date
- Sep 18, 2014