Why it was recalled
Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in the labeling.
Product description
Dermatend Ultra, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Glycerin, Butter of Zinc, Germall Plus, 0.34 OZ (10g) container, Solace International, Inc., Reno, NV 89509, USA
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Amazon US and Amazon UK
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-1586-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 28, 2014
- FDA report date
- Sep 24, 2014
- Quantity
- 1249 containers and kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Solace International Inc
Original FDA data
Every field from FDA enforcement report D-1586-2014, exactly as published.
Show all FDA fields
- City
- Reno
- State
- NV
- Status
- Terminated
- Country
- United States
- Event ID
- 69135
- Address
- 80 Continental Dr Ste 101
- Code information
- All lots
- Postal code
- 89509-3440
- Report date
- Sep 24, 2014
- Product type
- Drugs
- Recall number
- D-1586-2014
- Classification
- Class II
- Recalling firm
- Solace International Inc
- Product quantity
- 1249 containers and kits
- Termination date
- Nov 17, 2015
- Reason for recall
- Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in the labeling.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dermatend Ultra, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Glycerin, Butter of Zinc, Germall Plus, 0.34 OZ (10g) container, Solace International, Inc., Reno, NV 89509, USA
- Distribution pattern
- Amazon US and Amazon UK
- Recall initiation date
- Aug 28, 2014
- Initial firm notification
- Press Release
- Center classification date
- Sep 16, 2014