Terminated Class II

National Enzyme Co

Recall F-0806-2014 · Forsyth, MO

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);

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.

Quantity affected

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

Recall type

Voluntary: Firm initiated

Lot / code info

Lot #'s: 54651001, 83451000, and 92566001

Timeline

30 Oct 2013 initiated 13 Dec 2013 classified 25 Dec 2013 reported 3 Mar 2015 terminated

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