FDA Food Recalls

Recalls / Class II

Class IIF-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".

Type
Food
Affected lot / code info
All products manfactured since 6/1/2011
Quantity
1,372 units

Why it was recalled

This products contain Kratom.

Recalling firm

Firm
Nuevotanicals
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
7001 E Lancaster Ave Ste 129, N/A, Fort Worth, Texas 76112-7268

Distribution

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

Timeline

Recall initiated
2014-07-01
FDA classified
2015-06-08
Posted by FDA
2015-06-17
Terminated
2017-03-02
Status
Terminated

Source: openFDA Food Enforcement endpoint. Recall record F-2413-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings.

Class II food recall: Kr8om Max3 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, T… · FDA Food Recalls