Testosterone Cypionate-Testosterone Propionate mg/mL in cottonseed oil recalled over sterility concerns

Recall date

July 13, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

New Vitalis Pharmacy LLC dba New Vitalis Pharmacy recalls Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Onl…

Recall number

D-0944-2023

FDA classification

Class II

Brand / firm

New Vitalis Pharmacy LLC dba New Vitalis Pharmacy

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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