Baxter recalls Norepinephrine Bitartrate injection due to incorrect overwrap labeling. This could lead to incorrect dosing if used without checking the primary label. Affected units have NDC 0338-0108-20.
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.
Baxter Healthcare is recalling Norepinephrine Bitartrate injection vials because the overwrap label incorrectly states the concentration as 4 mg/250mL instead of the correct 8 mg/250mL. This labeling error could cause incorrect dosing if the product is used without verifying the primary label.
The overwrap label incorrectly states the product strength as 4 mg/250mL, but the primary bag label correctly states it as 8 mg/250mL. If healthcare workers rely on the overwrap label instead of the primary label, they could administer the wrong dose.
Healthcare professionals who use this injection for intravenous infusion. The risk is low as the primary label correctly identifies the concentration.
Check for vials with NDC 0338-0108-20, Lot 23I21G64, expiring 07/31/2024. The product is labeled for intravenous infusion only and requires a prescription.
Check the primary bag label for the correct concentration of 8 mg/250mL before use.
Yes, the primary bag label correctly identifies the concentration as 8 mg/250mL. The overwrap label error does not affect safety if the primary label is checked.
Check the primary bag label for the correct concentration. If it matches, use it safely. If not, contact Baxter Healthcare for guidance.
Look for NDC 0338-0108-20, Lot 23I21G64, expiring 07/31/2024. The product is for intravenous infusion only and requires a prescription.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0336-2024 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall D-0336-2024 from Baxter Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
