PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: July 26, 2017 Initiated: June 26, 2017 #D-0996-2017

Product Description

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

Reason for Recall

Lack of Assurance of Sterility; media fill failure at manufacturer

Details

Recalling Firm
PharMedium Services, Llc
Units Affected
N/A
Distribution
Nationwide
Location
Sugar Land, TX

Frequently Asked Questions

What product was recalled?
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. Recalled by PharMedium Services, Llc. Units affected: N/A.
Why was this product recalled?
Lack of Assurance of Sterility; media fill failure at manufacturer
Which agency issued this recall?
This recall was issued by the FDA Drug on July 26, 2017. Severity: Moderate. Recall number: D-0996-2017.