Potassium Phosphate Sodium Chloride (PharMedium) – Sterility Failure (2017)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL in 250 mL Intravia Bag Service Code 2K5290 NDC# 61553-290-11, b) 500 mL in 500 mL Intravia Bag Service Code 2K5285 NDC# 61553-285-03, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749
Brand
PharMedium Services, Llc
Lot Codes / Batch Numbers
Lots: a) 171180027S Exp. 7/29/2017, 171220058D Exp. 8/1/2017, 171230013S Exp. 8/2/2017, 171360008S Exp. 8/14/2017, 171360019D Exp. 8/15/2017, 171380085D Exp. 8/17/2017, 171430069D Exp. 8/22/2017, 171560025D Exp. 9/4/2017, b) 171240007S Exp. 8/3/2017, 171280055D Exp. 8/7/2017, 171320003D Exp. 8/10/2017, 171320008S Exp. 8/13/2017, 171360005S Exp. 8/14/2017, 171370011S Exp. 8/16/2017, 171380086D Exp. 8/17/2017, 171500071D Exp. 8/29/2017
Products Sold
Lots: a) 171180027S Exp. 7/29/2017, 171220058D Exp. 8/1/2017, 171230013S Exp. 8/2/2017, 171360008S Exp. 8/14/2017, 171360019D Exp. 8/15/2017, 171380085D Exp. 8/17/2017, 171430069D Exp. 8/22/2017, 171560025D Exp. 9/4/2017; b) 171240007S Exp. 8/3/2017, 171280055D Exp. 8/7/2017, 171320003D Exp. 8/10/2017, 171320008S Exp. 8/13/2017, 171360005S Exp. 8/14/2017, 171370011S Exp. 8/16/2017, 171380086D Exp. 8/17/2017, 171500071D Exp. 8/29/2017
PharMedium Services, Llc is recalling Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL in 250 mL Intravia Bag S due to Lack of Assurance of Sterility; media fill failure at manufacturer. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility; media fill failure at manufacturer
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026