PHENYLephrine HCl 10 mg in 0 recalled over sterility concerns

Recall date

July 14, 2017

Source

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

Official notice title

SCA Pharmaceuticals recalls PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL), Total Volume 100 mL Single Dose…

Recall number

D-1004-2017

FDA classification

Class II

Brand / firm

SCA Pharmaceuticals

Sold / distributed

Nationwide in the USA

Why it was recalled

Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0810-32.