Why it was recalled
Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.
Product description
Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle
Lot numbers, UPCs & expiration codes
Bottles stamped MFD: 03.07.2016 EXP: 03.06.2018
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-0223-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Oct 28, 2016
- FDA report date
- Dec 28, 2016
- Quantity
- 74 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Love My Tru Body
Original FDA data
Every field from FDA enforcement report D-0223-2017, exactly as published.
Show all FDA fields
- City
- McDonough
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 75537
- Address
- 289 Jonesboro Rd Ste 106
- Code information
- Bottles stamped MFD: 03.07.2016 EXP: 03.06.2018
- Postal code
- 30253-3725
- Report date
- Dec 28, 2016
- Product type
- Drugs
- Recall number
- D-0223-2017
- Classification
- Class I
- Recalling firm
- Love My Tru Body
- Product quantity
- 74 bottles
- Termination date
- Apr 6, 2017
- Reason for recall
- Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 28, 2016
- Initial firm notification
- Letter
- Center classification date
- Dec 22, 2016