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Recall Observatory FDA recall evidence

Drug product

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.

D-0963-2016

August 24, 2015

Class I

Product summary

Firm
Novacare, LLC
Event
Event 71989
Status
Terminated
Classification
Class I
Quantity
N/A
Official record key
drug-enforcement:D-0963-2016

Official wording

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

Code information: unknown

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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