FDA recall record

National Enzyme Co 3989 Bulk TPP TEC DIGEST powder, Transformation Enzyme recall — FDA F-0738-2014

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

Class IIclassification
F-0738-2014official record ID
Dec 25, 2013report date

Recall record at a glance

Official recordF-0738-2014
CategoryFood Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmNational Enzyme Co
Report dateDec 25, 2013
Recall initiation dateOct 30, 2013
Quantity103.14 Kg
LocationForsyth, MO, United States

Official product description

3989 Bulk TPP TEC DIGEST powder, Transformation Enzyme Corporat, packaged in varying quantities in poly bags within corrugated containers. SKU 81814

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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