Why it was recalled
Marketed Without an Approved NDA/ANDA: All lots of the dietary supplement Slimdia Revolution are being recalled because they contain sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.
Product description
SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19685 Varda Ave., Buena Park, CA.
Lot numbers, UPCs & expiration codes
There are no manufacturing codes associated with the product.
Where it was sold
Korea
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-165-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 19, 2012
- FDA report date
- Feb 27, 2013
- Quantity
- unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- P & J Trading Co
Original FDA data
Every field from FDA enforcement report D-165-2013, exactly as published.
Show all FDA fields
- City
- Fullerton
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 63942
- Address
- 1941 W Commonwealth Ave
- Address (line 2)
- Suite B
- Code information
- There are no manufacturing codes associated with the product.
- Postal code
- 92833-3042
- Report date
- Feb 27, 2013
- Product type
- Drugs
- Recall number
- D-165-2013
- Classification
- Class I
- Recalling firm
- P & J Trading Co
- Product quantity
- unknown
- Termination date
- Mar 25, 2013
- Reason for recall
- Marketed Without an Approved NDA/ANDA: All lots of the dietary supplement Slimdia Revolution are being recalled because they contain sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19685 Varda Ave., Buena Park, CA.
- Distribution pattern
- Korea
- Recall initiation date
- Dec 19, 2012
- Initial firm notification
- Press Release
- Center classification date
- Feb 15, 2013