Drug 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
D-376-2014
Product summary
- Event
- Event 66043
- Status
- Terminated
- Classification
- Class I
- Quantity
- 32 bottles of 6 capsules each
- Official record key
drug-enforcement:D-376-2014
Official wording
Reason: Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil
Code information: All Lots
Distribution pattern: CA, FL and UT
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil