FDA recall F-2413-2015

Product

Kr8om Max3 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 3 capsules; Kr8om Max10 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 10 capsules; Capsules are packed in a round, clear plastic screw-on lid container. Dosage is "1 capsule after a meal", each capsules is "4.4 g leaf equiv".

Reason for recall

This products contain Kratom.

Distribution

Alabama, Arizona, California, Florida, Illinois, Nevada, New York, Ohio, Oklahoma, Oregon, Texas, and Virginia.

Key facts

Status

Terminated

Initiation date

2014-07-01

Report date

2015-06-17

Termination date

2017-03-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fort Worth, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-2413-2015