Thorne Research Inc recalls Captomer-250 [succinic acid (from 250 mg DMSA)] capsules, 162 mg, 45-count bottles, Manufactured By: Thorne Research, In
Recalled June 25, 2014 · FDA recall D-1384-2014 · Thorne Research
Hazard
Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs. · FDA Class II
Units
unknown
Sold at
Nationwide, New Zealand, England, German, Sweden, Ukraine, and Egypt.
Description
Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs.
Product
Captomer-250 [succinic acid (from 250 mg DMSA)] capsules, 162 mg, 45-count bottles, Manufactured By: Thorne Research, Inc., P.O. Box 25, Dover, Idaho 83825, UPC 6 93749 73502 1
Manufacturer(s)
Thorne Research Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →