Potassium PHOSphate in 5% Dextrose Injection recalled over sterility concerns

Recall date

June 26, 2017

Source

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

Official notice title

PharMedium Services, Llc recalls Potassium PHOSphate in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intravia Bag, Rx Only, PharMEDium Services, LLC…

Recall number

D-0995-2017

FDA classification

Class II

Brand / firm

PharMedium Services, Llc

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility; media fill failure at manufacturer

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 in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5310 NDC# 61553-310-41