FDA recall record

National Enzyme Co Bulk A216 MRM DPPIV DIGEST BULK powder recall — FDA F-0778-2014

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

Class IIclassification
F-0778-2014official record ID
Dec 25, 2013report date

Recall record at a glance

Official recordF-0778-2014
CategoryFood Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmNational Enzyme Co
Report dateDec 25, 2013
Recall initiation dateOct 30, 2013
Quantity52.8 kg of powder
LocationForsyth, MO, United States

Official product description

Bulk A216 MRM DPPIV DIGEST BULK powder (SKU 83217), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)

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

Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.

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