FDA-Drug2017-07-26Class II

Potassium PHOSphate in 5% Dextrose Injection, 15 mMol in 250 mL in 250 mL Intravia Bag Service, Rx Only. PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5300 NDC# 61553-300-11

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 5% Dextrose Injection, 15 mMol in 250 mL in 250 mL Intravia Bag Service, Rx Only. PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5300 NDC# 61553-300-11

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0997-2017

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