Drug product
Formula 82F (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone Acetonide 0.01%/Finasteride 0.25%), 0.5 FL OZ (15 mL) bottle MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600.
D-1423-2020
Product summary
- Firm
- MasterPharm LLC
- Event
- Event 85992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 462 units
- Official record key
drug-enforcement:D-1423-2020
Official wording
Reason: Lack of Processing Controls (lack of assurance of conformity to specifications).
Code information: 01-15-2020:70@3, 01-09-2020:48@2, BUD 7/7/2020 01-20-2020:79@11, 01-23-2020:55@11, BUD 7/18/2020 01-29-2020:18@1, 02-03-2020:89@8, BUD 7/26/2020
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls