The Recall Desk

FDA (Drugs) recall action 68222

Thorne Research Inc recalled 2 products on 2014-06-25

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2014-06-25
Critical
0
Units
—

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • ModerateFDA (Drugs)··2014-06-25

    Thorne Research Recalls Captomer-250 Capsules Marketed Without Approval

    Thorne Research is recalling Captomer-250 capsules because they are marketed as dietary supplements but contain DMSA, an active drug ingredient, making them 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
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2014-06-25

    Thorne Research Recalls Captomer Capsules Marketed Without FDA Approval

    Thorne Research is recalling Captomer capsules because they are marketed as dietary supplements but contain DMSA, an active drug ingredient, making them unapproved new drugs.

    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
    Category
    Distribution
    0 states