Carolina Infusion product recalled over sterility concerns

Recall date

August 26, 2022

Source

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

Official notice title

Carolina Infusion recalls TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, S…

Recall number

D-1524-2022

FDA classification

Class II

Brand / firm

Carolina Infusion

Sold / distributed

Nationwide in the USA.

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

TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.