Recalls / Class II

Class IIF-0806-2014

Product

Dietary Supplements packaged in the following configurations: (1) No-Fenol Chewable, Multi-Enzyme Product for Digestion of Phenolic Foods and Fibers, packaged 180-chewable tablets bottles (SKU 54651). Firm name on the label is Houston Nutraceutical Inc. (HNI), Siloam, AR; (2) Bulk C613 Houston No-Fenol Bulk powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83451); (3) Bulk C613 Houston No-Fenol Chew T chewable tablets, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92566);

Type

Food

Affected lot / code info

Lot #'s: 54651001, 83451000, and 92566001

Quantity

594 bottles, 0.23 kg of powder, and 20,580 bulk capsules

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-0806-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings.