FDA recall D-0523-2020

New Vitalis Pharmacy LLC dba New Vitalis Pharmacy · Class II · drug

Product

Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial, New Vitalis Pharmacy

Reason for recall

Lack of sterility assurance.

Distribution

Distributed Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2019-10-01
Report date
2019-12-04
Termination date
2023-03-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Louisville, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0523-2020