ESTRADIOL VALERATE 5MG/ML MDV INJ recalled over sterility concerns

Recall date

August 13, 2021

Source

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

Official notice title

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

Recall number

D-0037-2022

FDA classification

Class II

Brand / firm

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Sold / distributed

494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.

Why it was recalled

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

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 VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx