Drug product
BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
D-0220-2017
Product summary
- Event
- Event 73973
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1000 bottles
- Official record key
drug-enforcement:D-0220-2017
Official wording
Reason: Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.
Code information: All lots
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.