National Enzyme Co

Recall #F-0787-2014 · Initiated 2013-10-30

Plain-language summary

by FoodRecallsDB.info

What happened

National Enzyme Co is recalling several dietary supplement products (ActiFIT, Actizyme, and Digest Miracle brands) because a raw material used in them may contain chloramphenicol, an antibiotic that is not approved for use in dietary supplements sold in the United States. The recall affects both bulk tablets and 60-tablet bottles distributed nationwide and internationally.

Who is at risk

Anyone who has purchased these supplements should be aware of this recall, though the risk level is considered moderate (Class II) by the FDA.

What to do

Check your home for these products using the SKU numbers listed (92275 for bulk tablets, 54955 for bottles). If you have them, stop using them and contact the manufacturer or your retailer for a refund or disposal instructions.

Product

Dietary Supplements packaged in the following configurations: (1) Bulk B341 Shanghai Actizyme Tab6 tablets, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92275); (2) ActiFIT, Actizyme, Digest Miracle, packaged in 60-tablet bottles (SKU 54955). Firm name on the label is ActiFit Biotechnology Co, Bellevue, WA.

Reason for recall

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

Quantity affected

321,893 bulk capsules, 3714 bottles.

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 #'s: 92275001, 92275003, and 54955000

Voluntary / mandated

Voluntary: Firm initiated

Initial notification

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

Terminated

2015-03-03