Drug product
Formula 82M (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone acetonide 0.01%), a) 0.5 FL OZ (15 mL), b) 2 FL OZ (60 mL) bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
D-1424-2020
Product summary
- Firm
- MasterPharm LLC
- Event
- Event 85992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 543 units
- Official record key
drug-enforcement:D-1424-2020
Official wording
Reason: Lack of Processing Controls (lack of assurance of conformity to specifications).
Code information: 01-17-2020:45@4, 01-13-2020:40@27, BUD 7/7/2020 01-21-2020:43@11, BUD 7/18/2020 01-28-2020:88@15, 01-31-2020:73@6, BUD 7/26/2020 02-12-2020:43@16, 02-17-2020:86@5, BUD 8/10/2020 02-21-2020:23@1, BUD 8/16/2020
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls