Drug product
Progesterone 150 mg Troche, 30 troches MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
D-1428-2020
Product summary
- Firm
- MasterPharm LLC
- Event
- Event 85992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 330 troches
- Official record key
drug-enforcement:D-1428-2020
Official wording
Reason: Lack of Processing Controls (lack of assurance of conformity to specifications).
Code information: 02-06-2020:26@15, BUD 8/4/2020 02-07-2020:18@1, BUD 8/5/2020 02-12-2020:43@6, BUD 8/10/2020
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls