FDA recall record

National Enzyme Co Dietary Supplements packaged in the following configuration recall — FDA F-0784-2014

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

Class IIclassification
F-0784-2014official record ID
Dec 25, 2013report date

Recall record at a glance

Official recordF-0784-2014
CategoryFood Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmNational Enzyme Co
Report dateDec 25, 2013
Recall initiation dateOct 30, 2013
Quantity1751 bottles.
LocationForsyth, MO, United States

Official product description

Dietary Supplements packaged in the following configuration: (1) Competitive Nutrition, Healthy Digest, packaged in 90-capsule bottles (SKU 83314). Firm name on the label is Competitive Nutrition, Monaca, PA; (2) New Earthlings Nutritionals, Healthy Digest, Complete Digestive Enzyme Formula packaged in 90-capsule bottles (SKU 54626). Firm name on the label is Guest Chiropractic Clinic, Inman, SC; (3) Doctor Faz, Healthy Digest, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54555). Firm name on the bottle is National Enzyme Company, Forsyth, MO; (4) Healthy Digest, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54784). Firm name on the bottle is Natural Solutions 101, Walnut Shade, MO; (5) NEC, Healthy Digest, Full Spectrum Digestion, packaged in 90-capsule bottles (SKU 54169). Firm name on the label is National Enzyme Company, Forsyth, MO; (6) Solutions Rx, DIGESTIVE WELLNESS, COMPLETE DIGESTIVE ENZYME FORMULA, packaged in 90-capsule bottles (SKU 54608). Firm name on the bottle is Pharmacy & Healthcare Solutions, Saltillo, MS; (7) The Essentials, Ultra Professional, Digestive Essentials, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54512). Firm name on the label is Ask The Pharmacist, Oakmont, PA; (8) FeelIt Healthy Digest, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54872). Firm name on the label is Victory International Group, Irvine, CA;

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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