FDA recall F-0784-2014

National Enzyme Co · Class II · food

Product

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-caps

Reason for recall

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

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.

Key facts

Status
Terminated
Initiation date
2013-10-30
Report date
2013-12-25
Termination date
2015-03-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Forsyth, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-0784-2014