Recalls / Class II

Class IIF-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;

Type

Food

Affected lot / code info

Lot #: 53985002, 54389001, and 54632000

Quantity

31 bottles

Why it was recalled

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

Recalling firm

Firm

National Enzyme Co

Notification channel

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Type

Voluntary: Firm initiated

Address

10203 State Highway 76, N/A, Forsyth, Missouri 65653-5445

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2013-10-30

FDA classified

2013-12-13

Posted by FDA

2013-12-25

Terminated

2015-03-03

Status

Terminated

Source: openFDA Food Enforcement endpoint. Recall record F-0785-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings.