Alprostadil 20 mcg/mL Injectable recalled over sterility concerns

Recall date

September 21, 2016

Source

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

Official notice title

Wells Pharmacy Network LLC recalls Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL

Recall number

D-0337-2017

FDA classification

Class II

Brand / firm

Wells Pharmacy Network LLC

Sold / distributed

Nationwide

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

Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL