Testosterone Cypionate + Progesterone recalled over manufacturing violations

Recall date

July 12, 2017

Source

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

Official notice title

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical recalls Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmace…

Recall number

D-1040-2017

FDA classification

Class II

Brand / firm

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Sold / distributed

There were only one customer in California

Why it was recalled

CGMP Deviations

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 + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angeles, CA 90025