Why it was recalled
Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine.
Product description
BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481
Lot numbers, UPCs & expiration codes
MFD: 05.06.2016 EXP: 05.05.2018
Where it was sold
U.S.A. 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-0471-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 7, 2017
- FDA report date
- Jan 31, 2018
- Quantity
- 5 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- BotanicalNow
Original FDA data
Every field from FDA enforcement report D-0471-2018, exactly as published.
Show all FDA fields
- City
- Donna
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 78720
- Address
- 17260 Dillon Rd
- Code information
- MFD: 05.06.2016 EXP: 05.05.2018
- Postal code
- 78537-5199
- Report date
- Jan 31, 2018
- Product type
- Drugs
- Recall number
- D-0471-2018
- Classification
- Class I
- Recalling firm
- BotanicalNow
- Product quantity
- 5 bottles
- Termination date
- Sep 25, 2020
- Reason for recall
- Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Dec 7, 2017
- Initial firm notification
- Letter
- Center classification date
- Feb 20, 2018