SCA Pharmaceuticals recalls Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only,…

Recall date

June 21, 2017

Source

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

Recall number

D-0978-2017

FDA classification

Class II

Brand / firm

SCA Pharmaceuticals

Sold / distributed

LA, PA, NY, WI

Why it was recalled

Lack of sterility assurance

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

What was recalled

Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-32