D-0963-2016 Class I Terminated

Recalled by Novacare, LLC — Murray, UT

FDA drug recall D-0963-2016 was initiated by Novacare, LLC on August 24, 2015 and is designated Class I. Reason for recall: Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. The recall status is terminated (terminated August 30, 2017). Affected quantity: N/A.

Recall Details

Product Type
Drugs
Report Date
June 15, 2016
Initiation Date
August 24, 2015
Termination Date
August 30, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

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.

Reason for Recall

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

Distribution Pattern

Nationwide

Code Information

unknown