Recall record at a glance
| Official record | F-0806-2014 |
|---|---|
| Category | Food Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | National Enzyme Co |
| Report date | Dec 25, 2013 |
| Recall initiation date | Oct 30, 2013 |
| Quantity | 594 bottles, 0.23 kg of powder, and 20,580 bulk capsules |
| Location | Forsyth, MO, United States |
Official product description
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);
Why the product was recalled
Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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