FDA Recall D-376-2014
Fabscout Entertainment, Inc · Ft Lauderdale, FL
Class I — life-threatening Terminated 2737 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Evil Root 1200 mg, supplied in 6 capsules per bottle, Manufacturer: Tibet Shengyang Health Medicine Co.,Ltd. Address: No. 98, Min zu Road, Lhasa
Reason for recall
Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil
Recall record
- Recall number
D-376-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- CA, FL and UT
- Recall initiated
- 2013-08-14
- Classified by FDA Center
- 2013-12-18
- FDA published
- 2013-12-25
- Terminated
- 2021-02-10
- Recalling firm
- Fabscout Entertainment, Inc
- Firm location
- Ft Lauderdale, FL