FDA recall F-0759-2014

National Enzyme Co · Class II · food

Product

Dietary Supplements packaged in the following configurations: (1) Natural Health Industries, Opti-Zyme HP, packaged in 90-capsule bottles (SKU 54654). Firm name on the label is Natural Health Industries, Clarmonte, CA; (2) 8974 Enzymes Inc Natural Hea, packaged in unlabeled, 90-capsule bottles (SKU 54756);

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-0759-2014