Drug product
AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City.
D1612-2014
Product summary
- Event
- Event 68218
- Status
- Terminated
- Classification
- Class I
- Quantity
- 460 boxes
- Official record key
drug-enforcement:D1612-2014
Official wording
Reason: Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
Code information: All lots
Distribution pattern: To retailers in MD, TX, FL, PA, IL, NJ, IN, LA, WA, ME, SC
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.