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

FDA recall notice · announced June 25, 2014 · Thorne Research

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

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.

Notes

Distribution: Nationwide, New Zealand, England, German, Sweden, Ukraine, and Egypt.
Lot/code information: All lot codes
Quantity: unknown
Status: Terminated
Products in this recall event:
- Captomer [succinic acid (from 100 mg DMSA)] capsules, 65 mg, 45-count bottles, Manufactured By: Thorne Research, Inc., P.O. Box 25, Dover, Idaho 83825, UPC 6 93749 74002 5 (D-1383-2014)
- 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 (D-1384-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.