Recalls / Class II
Class IID-1424-2020
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
- Affected lot / code info
- 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
Why it was recalled
Lack of Processing Controls (lack of assurance of conformity to specifications).
Recalling firm
- Firm
- MasterPharm LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 11502 Liberty Ave Fl 2, N/A, South Richmond Hill, New York 11419-1902
Distribution
- Quantity
- 543 units
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2020-07-02
- FDA classified
- 2020-07-29
- Posted by FDA
- 2020-08-05
- Terminated
- 2024-02-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1424-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.