ESTRADIOL CYP/TEST CYP- SS OIL- 2MG/50MG/ML INJECTABLE recalled over sterility concerns

Recall date

December 22, 2022

Source

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

Official notice title

Pharmacy Innovations recalls ESTRADIOL CYP/TEST CYP- SS OIL- 2MG/50MG/ML (1.5ML VIAL) INJECTABLE; ESTRADIOL CYP/TEST CYP -SS OIL- 2MG/25MG/ML (1ML V…

Recall number

D-0206-2023

FDA classification

Class II

Brand / firm

Pharmacy Innovations

Sold / distributed

Nationwide in the USA

Why it was recalled

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

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 CYP/TEST CYP- SS OIL- 2MG/50MG/ML (1.5ML VIAL) INJECTABLE; ESTRADIOL CYP/TEST CYP -SS OIL- 2MG/25MG/ML (1ML VIAL) INJECTABLE; ESTRADIOL CYP-CS OIL- 5MG/ML (1.25ML VIAL) INJECTABLE; ESTRADIOL CYP-GS OIL- 5MG/ML (1ML VIAL) INJECTABLE ESTRADIOL CYP-SS OIL- 5MG/ML (1.5ML VIAL) INJECTABLE; ESTRADIOL CYP-SS OIL- 5MG/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.