National Enzyme Co

Recall #F-0777-2014 · Initiated 2013-10-30

Plain-language summary

by FoodRecallsDB.info

What happened

National Enzyme Co is recalling bulk digestive supplement capsules (Phion Complete Digestiv, SKU 92123) because a raw ingredient may contain trace amounts of chloramphenicol, an antibiotic that isn't approved for use in dietary supplements sold in the U.S. The affected product was distributed nationwide and to several countries including Canada, the UK, China, and others.

Who is at risk

Anyone who purchased this bulk supplement product should be aware of the recall, though the risk is considered low based on the FDA's classification.

What to do

If you have this product, stop using it and contact National Enzyme Co or check the FDA's website for return instructions. This recall primarily affects bulk products sold to distributors and retailers rather than individual consumers, so check with the store or company where you purchased it if you're unsure whether you have an affected product.

Product

Bulk A213 Phion Complete Digestiv capsules (SKU 92123), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)

Reason for recall

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

Quantity affected

212,381 bulk capsules.

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.

Lot / code info

Lot #: 92123004 and 92123005

Voluntary / mandated

Voluntary: Firm initiated

Initial notification

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

Terminated

2015-03-03