Drug product
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
D-0003-2025
Product summary
- Event
- Event 94949
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 729
- Official record key
drug-enforcement:D-0003-2025
Official wording
Reason: Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Code information: All lots
Distribution pattern: Nationwide US (2014), Israel (2), Canada (12), Republic of Kosovo (1), Pakistan (1), Australia (3), Morocco (1), United Kingdom (1)
Derived failure modes
-
Unknown
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.