FDA-Drug2017-06-21Class III

Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Service Code 2K5288, NDC# 61553-0288-48, Total Volume 100.00 mL incorrectly labeled as 103.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

Pharmedium Services, LLC
Hazard

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

Sold states
Nationwide in the USA
Affected count
672 bags
Manufactured in
150 N Field Dr Ste 350, N/A, Lake Forest, IL, United States
Products
Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Service Code 2K5288, NDC# 61553-0288-48, Total Volume 100.00 mL incorrectly labeled as 103.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0911-2017

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