Estradiol 12 recalled over manufacturing violations

Recall date

April 19, 2017

Source

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

Official notice title

Qualgen recalls Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile O…

Recall number

D-0894-2017

FDA classification

Class II

Brand / firm

Qualgen

Sold / distributed

Nationwide.

Why it was recalled

CGMP deviations- Lack of Quality Assurance

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 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-012-01