D-1384-2014 Class II Terminated
FDA drug recall D-1384-2014 was initiated by Thorne Research Inc on June 12, 2014 and is designated Class II. 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 … The recall status is terminated (terminated October 15, 2014). Affected quantity: unknown.
Recall Details
- Product Type
- Drugs
- Report Date
- June 25, 2014
- Initiation Date
- June 12, 2014
- Termination Date
- October 15, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- unknown
Product Description
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.
Distribution Pattern
Nationwide, New Zealand, England, German, Sweden, Ukraine, and Egypt.
Code Information
All lot codes