FDA recall D-0047-2022

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy · Class II · drug

Product

TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx

Reason for recall

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Distribution

494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.

Key facts

Status
Terminated
Initiation date
2021-08-13
Report date
2021-11-03
Termination date
2023-04-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mesa, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0047-2022