Status
Terminated
Drug Enforcement D-376-2014
Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil
Classification
Class I
Report Date
December 25, 2013
Termination Date
February 10, 2021
Product Information
- 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
- Product quantity
- 32 bottles of 6 capsules each
- Reason for recall
- Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- CA, FL and UT
Location & Firm
- Recalling firm
- Fabscout Entertainment, Inc
- Address
-
1458 NW 23rd Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-376-2014
- Event ID
- 66043
- Recall initiation date
- August 14, 2013
- Center classification date
- December 18, 2013
- Code info
- All Lots
- More code info
- —