Potassium PHOSphate in 0 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 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 150 mL Intravia Bag (NDC 61553-288-48) S…

Recall number

D-0986-2017

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 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 150 mL Intravia Bag (NDC 61553-288-48) Service Code: 2K5288, and b) 250 mL in 250 mL Intravia Bag (NDC 61553-281-11) Service Code: 2K5281, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749