Testosterone Cypionate 200mg/ml a) -vial recalled over sterility concerns

Recall date

March 7, 2022

Source

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

Official notice title

TMC Acquisition LLC dba Tailor Made Compounding recalls Testosterone Cypionate (GSO) 200mg/ml a) 2 mL-vial, b) 4 mL-vial, c) 5 mL-vial, d) 10 mL-vial, Room temperature, Tailor…

Recall number

D-1231-2022

FDA classification

Class II

Brand / firm

TMC Acquisition LLC dba Tailor Made Compounding

Sold / distributed

Nationwide USA and Puerto Rico

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 (GSO) 200mg/ml a) 2 mL-vial, b) 4 mL-vial, c) 5 mL-vial, d) 10 mL-vial, Room temperature, Tailor Made Compounding