Drug product
Progesterone 200 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
D-1431-2020
Product summary
- Firm
- MasterPharm LLC
- Event
- Event 85992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 troches
- Official record key
drug-enforcement:D-1431-2020
Official wording
Reason: Lack of Processing Controls (lack of assurance of conformity to specifications).
Code information: 02-06-2020:24@4, 02-06-2020:60@3, 02-06-2020:65@2, BUD 8/4/2020
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls