FDA Drug Class II — Moderate

Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5284 NDC# 61553-284-48

Hazard

Lack of Assurance of Sterility; media fill failure at manufacturer

Products

Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service C
Brand
PharMedium Services, Llc
UPC
Lots: 171220061D Exp. 8/1/2017, 171250023D Exp. 8/6/2017, 171430008D Exp. 8/22/2017, 171450015D Exp. 8/24/2017, 171510062D Exp. 8/30/2017

Units Affected

N/A