FDA-Drug2017-07-26Class II
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
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, 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0996-2017Don't want to check this manually?
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