Drug product
Black Ant, 2800 mg, four capsules per box, Manufacturer Qinghai Baojiantang Pharmaceutical Co., Ltd.
D-1613-2014
Product summary
- Event
- Event 68218
- Status
- Terminated
- Classification
- Class I
- Quantity
- 136 boxes
- Official record key
drug-enforcement:D-1613-2014
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.