Drug product
Tadalafil 7 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
D-1440-2020
Product summary
- Firm
- MasterPharm LLC
- Event
- Event 85992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12000 capsules
- Official record key
drug-enforcement:D-1440-2020
Official wording
Reason: Lack of Processing Controls (lack of assurance of conformity to specifications).
Code information: 01-08-2020:45@16, BUD 7/6/2020 01-22-2020:02@19, BUD 7/20/2020 02-13-2020:05@3, BUD 8/11/2020 02-24-2020:95@12, BUD 8/22/2020
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls