Why it was recalled
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Product description
Thin and Slim MaxOut Body Max Out FX Fat Burner with Ephedra packaged in containers of 60 capsules. Distributed by Teamtrade, Inc., Ft. Lauderdale, FL. 1-866-MaxOut www.MaxOutBODY.com.
Lot numbers, UPCs & expiration codes
unknown
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-0963-2016
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 24, 2015
- FDA report date
- Jun 15, 2016
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novacare, LLC
Original FDA data
Every field from FDA enforcement report D-0963-2016, exactly as published.
Show all FDA fields
- City
- Murray
- State
- UT
- Status
- Terminated
- Country
- United States
- Event ID
- 71989
- Address
- 312 W 6100 S
- Code information
- unknown
- Postal code
- 84107-6990
- Report date
- Jun 15, 2016
- Product type
- Drugs
- Recall number
- D-0963-2016
- Classification
- Class I
- Recalling firm
- Novacare, LLC
- Termination date
- Aug 30, 2017
- Reason for recall
- Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Thin and Slim MaxOut Body Max Out FX Fat Burner with Ephedra packaged in containers of 60 capsules. Distributed by Teamtrade, Inc., Ft. Lauderdale, FL. 1-866-MaxOut www.MaxOutBODY.com.
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 24, 2015
- Initial firm notification
- Letter
- Center classification date
- Jun 6, 2016