FentaNYL Citrate in 0 recalled over sterility concerns

Recall date

July 25, 2022

Source

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

Official notice title

SterRx, LLC recalls fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue…

Recall number

D-1332-2022

FDA classification

Class II

Brand / firm

SterRx, LLC

Sold / distributed

Nationwide within the United States

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

fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-327-02.