Estradiol 12 recalled over sterility concerns

Recall date

October 17, 2018

Source

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

Official notice title

Qualgen, LLC recalls Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 co…

Recall number

D-0226-2019

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

Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013