FDA recall D-0280-2020

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

Product

S-TESTOSTERONE CYP 100MG/ML in SESAME OIL, 5ml Rx only, Red Mountain Compounding Rx.

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2019-08-12
Report date
2019-11-13
Termination date
2023-04-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mesa, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0280-2020