Recall record at a glance
| Official record | D-1384-2014 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Thorne Research Inc. |
| Report date | Jun 25, 2014 |
| Recall initiation date | Jun 12, 2014 |
| Quantity | unknown |
| Location | Sandpoint, ID, United States |
Official 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
Why the product was 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.
Distribution information
Nationwide, New Zealand, England, German, Sweden, Ukraine, and Egypt.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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