Why it was recalled
Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil
Product description
Evil Root 1200 mg, supplied in 6 capsules per bottle, Manufacturer: Tibet Shengyang Health Medicine Co.,Ltd. Address: No. 98, Min zu Road, Lhasa
Lot numbers, UPCs & expiration codes
All Lots
Where it was sold
CA, FL and UT
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-376-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 14, 2013
- FDA report date
- Dec 25, 2013
- Quantity
- 32 bottles of 6 capsules each
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fabscout Entertainment, Inc
Original FDA data
Every field from FDA enforcement report D-376-2014, exactly as published.
Show all FDA fields
- City
- Ft Lauderdale
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 66043
- Address
- 1458 NW 23rd Ave
- Code information
- All Lots
- Postal code
- 33311-5147
- Report date
- Dec 25, 2013
- Product type
- Drugs
- Recall number
- D-376-2014
- Classification
- Class I
- Recalling firm
- Fabscout Entertainment, Inc
- Product quantity
- 32 bottles of 6 capsules each
- Termination date
- Feb 10, 2021
- Reason for recall
- Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Evil Root 1200 mg, supplied in 6 capsules per bottle, Manufacturer: Tibet Shengyang Health Medicine Co.,Ltd. Address: No. 98, Min zu Road, Lhasa
- Distribution pattern
- CA, FL and UT
- Recall initiation date
- Aug 14, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Dec 18, 2013