Why it was recalled
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
Product description
LaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by LaBri's Body Health.
Lot numbers, UPCs & expiration codes
All lots remaining within expiry.
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-0122-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 24, 2017
- FDA report date
- Dec 27, 2017
- Quantity
- 1424 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- EZWeightLossTX LLC
Original FDA data
Every field from FDA enforcement report D-0122-2018, exactly as published.
Show all FDA fields
- City
- Corpus Christi
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 77817
- Address
- 3333 S Padre Island Dr
- Address (line 2)
- Suite 102
- Code information
- All lots remaining within expiry.
- Postal code
- 78415-2904
- Report date
- Dec 27, 2017
- Product type
- Drugs
- Recall number
- D-0122-2018
- Classification
- Class I
- Recalling firm
- EZWeightLossTX LLC
- Product quantity
- 1424 bottles
- Termination date
- Feb 10, 2021
- Reason for recall
- Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- LaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by LaBri's Body Health.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 24, 2017
- Initial firm notification
- Press Release
- Center classification date
- Dec 20, 2017