Why it 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.
Product description
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
Lot numbers, UPCs & expiration codes
All lot codes
Where it was sold
Nationwide, New Zealand, England, German, Sweden, Ukraine, and Egypt.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1383-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 12, 2014
- FDA report date
- Jun 25, 2014
- Quantity
- unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Thorne Research Inc
Original FDA data
Every field from FDA enforcement report D-1383-2014, exactly as published.
Show all FDA fields
- City
- Sandpoint
- State
- ID
- Status
- Terminated
- Country
- United States
- Event ID
- 68222
- Address
- 25820 Hwy 2 West
- Code information
- All lot codes
- Postal code
- 83864
- Report date
- Jun 25, 2014
- Product type
- Drugs
- Recall number
- D-1383-2014
- Classification
- Class II
- Recalling firm
- Thorne Research Inc
- Product quantity
- unknown
- Termination date
- Oct 15, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide, New Zealand, England, German, Sweden, Ukraine, and Egypt.
- Recall initiation date
- Jun 12, 2014
- Initial firm notification
- Visit
- Center classification date
- Jun 13, 2014