FDA recall D-0944-2023

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

Product

Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY 40213

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide

Key facts

Status
Ongoing
Initiation date
2023-07-13
Report date
2023-08-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Louisville, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0944-2023