Testosterone 25 mg pellet recalled over sterility concerns

Recall date

October 17, 2018

Source

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

Official notice title

Qualgen, LLC recalls Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC, Ed…

Recall number

D-0234-2019

FDA classification

Class II

Brand / firm

Qualgen, LLC

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 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC, Edmond, OK 73013