Why it was recalled
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug.
Product description
Magic Slim capsules (Ling Zhi, Ebony, Fox-nut, Tuckahoe, Seman Pruni, Dioscoreae, Wheat Germ, Nature Substance), 60-count bottles.
Lot numbers, UPCs & expiration codes
No lot code information or exp date on packaging.
Where it was sold
Nationwide
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-1221-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 10, 2013
- FDA report date
- Apr 16, 2014
- Quantity
- 2 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Slim Beauty USA
Original FDA data
Every field from FDA enforcement report D-1221-2014, exactly as published.
Show all FDA fields
- City
- Kearney
- State
- NE
- Status
- Terminated
- Country
- United States
- Event ID
- 67260
- Address
- 503 E 23rd St
- Code information
- No lot code information or exp date on packaging.
- Postal code
- 68847
- Report date
- Apr 16, 2014
- Product type
- Drugs
- Recall number
- D-1221-2014
- Classification
- Class I
- Recalling firm
- Slim Beauty USA
- Product quantity
- 2 bottles
- Termination date
- Mar 14, 2017
- Reason for recall
- Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Magic Slim capsules (Ling Zhi, Ebony, Fox-nut, Tuckahoe, Seman Pruni, Dioscoreae, Wheat Germ, Nature Substance), 60-count bottles.
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 10, 2013
- Initial firm notification
- Center classification date
- Apr 7, 2014