FDA recall D-1383-2014

Product

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

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.

Distribution

Nationwide, New Zealand, England, German, Sweden, Ukraine, and Egypt.

Key facts

Status

Terminated

Initiation date

2014-06-12

Report date

2014-06-25

Termination date

2014-10-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sandpoint, ID, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1383-2014