FDA-Drug2017-06-21Class II

VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2243, NDC# 61553-043-34, Total Volume 300.00 mL incorrectly labeled as 500.00 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
816 bags
Manufactured in
150 N Field Dr Ste 350, N/A, Lake Forest, IL, United States
Products
VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2243, NDC# 61553-043-34, Total Volume 300.00 mL incorrectly labeled as 500.00 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-0914-2017

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