Recalls / Class II
Class IID-1423-2020
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.
- Affected lot / code info
- 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
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
- 462 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-1423-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.