Why it was recalled
Marketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.
Product description
MAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in 36 count capsules in Green & Blue Boxes, Formulated and distributed by Olaax Corp, Lakeland, FL
Lot numbers, UPCs & expiration codes
All Lots
Where it was sold
Nationwide, Puerto Rico and Venezuela and Bolivia
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-600-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 12, 2013
- FDA report date
- Jun 19, 2013
- Quantity
- 600 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- OLAAX International
Original FDA data
Every field from FDA enforcement report D-600-2013, exactly as published.
Show all FDA fields
- City
- Bartow
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 64409
- Address
- 6105 Riverlake Blvd
- Code information
- All Lots
- Postal code
- 33830-7754
- Report date
- Jun 19, 2013
- Product type
- Drugs
- Recall number
- D-600-2013
- Classification
- Class I
- Recalling firm
- OLAAX International
- Product quantity
- 600 boxes
- Termination date
- Oct 1, 2019
- Reason for recall
- Marketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in 36 count capsules in Green & Blue Boxes, Formulated and distributed by Olaax Corp, Lakeland, FL
- Distribution pattern
- Nationwide, Puerto Rico and Venezuela and Bolivia
- Recall initiation date
- Feb 12, 2013
- Initial firm notification
- Telephone
- Center classification date
- Jun 13, 2013