Why it was recalled
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine.
Product description
LaBri's Body Health Atomic, 60 capsules
Lot numbers, UPCs & expiration codes
All lot codes, manufacturing codes and expiration dates.
Where it was sold
Product sold nationwide through internet sales. No foreign consignees were reported.
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-0867-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 28, 2017
- FDA report date
- May 31, 2017
- Quantity
- unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Envy Me
Original FDA data
Every field from FDA enforcement report D-0867-2017, exactly as published.
Show all FDA fields
- City
- Corp Christi
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 76858
- Address
- 7018 Southhaven Dr
- Code information
- All lot codes, manufacturing codes and expiration dates.
- Postal code
- 78412-4132
- Report date
- May 31, 2017
- Product type
- Drugs
- Recall number
- D-0867-2017
- Classification
- Class I
- Recalling firm
- Envy Me
- Product quantity
- unknown
- Termination date
- Nov 3, 2021
- Reason for recall
- Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- LaBri's Body Health Atomic, 60 capsules
- Distribution pattern
- Product sold nationwide through internet sales. No foreign consignees were reported.
- Recall initiation date
- Mar 28, 2017
- Initial firm notification
- Other
- Center classification date
- May 25, 2017