FDA recall F-0785-2014

Product

Dietary Supplements packaged in the following configuration: (1) NEC Healthy Pre Menopausal, Feminine Support for Active Women, packaged in 60-capsule bottles (SKU 54389). Firm name on the label is National Enzyme Company, Forsyth, MO; (2) Root 86, Healthy Pre Menopausal, Healthy Vitality In Active Women packaged in 60-capsule bottles (SKU 54632). Firm name on the label is Root 86, Ridgedale, MO;

Reason for recall

Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol

Distribution

Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.

Key facts

Status

Terminated

Initiation date

2013-10-30

Report date

2013-12-25

Termination date

2015-03-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Forsyth, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-0785-2014