PHENYLephrine HCL in 0 recalled over sterility concerns

Recall date

May 18, 2017

Source

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

Official notice title

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

Recall number

D-0879-2017

FDA classification

Class II

Brand / firm

SCA Pharmaceuticals

Sold / distributed

Nationwide in the USA

Why it was recalled

Lack of assurance of sterility: Product bags leaking at seam.

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 in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0810-32