FDAFDA · Food and drugs·Recall number D-0336-2024
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
Published February 28, 2024 · Recall initiated: January 23, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NOREPINEPHRINE BITARTRATE
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- Nationwide in the USA
- Lot
- Lot 23I21G64; Exp. 07/31/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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