FDA-Drug2017-07-26Class II

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

PharMedium Services, Llc
Hazard

Lack of Assurance of Sterility; media fill failure at manufacturer

Sold states
Nationwide
Affected count
N/A
Manufactured in
12620 W Airport Blvd Ste 130, N/A, Sugar Land, TX, United States
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 Code 2K5284 NDC# 61553-284-48

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0991-2017

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