FDA recall D-1424-2020

MasterPharm LLC · Class II · 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

Reason for recall

Lack of Processing Controls (lack of assurance of conformity to specifications).

Distribution

Nationwide in the U.S.

Key facts

Status
Terminated
Initiation date
2020-07-02
Report date
2020-08-05
Termination date
2024-02-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
South Richmond Hill, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1424-2020