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Recall Observatory FDA recall evidence

Drug 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

D-1383-2014

June 12, 2014

Class II

Product summary

Firm
Thorne Research Inc
Event
Event 68222
Status
Terminated
Classification
Class II
Quantity
unknown
Official record key
drug-enforcement:D-1383-2014

Official wording

Reason: 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.

Code information: All lot codes

Distribution pattern: Nationwide, New Zealand, England, German, Sweden, Ukraine, and Egypt.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.