FDA-Drug2024-02-28Class II
Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland. NDC: 0338-0108-20
Baxter Healthcare Corporation
Hazard
Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
Sold states
Nationwide in the USA
Affected count
13,000 bags
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland. NDC: 0338-0108-20
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0336-2024Don't want to check this manually?
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