Baxter Healthcare Corporation has recalled 13,000 bags of Norepinephrine Bitartrate (norepinephrine bitartrate) in 5% Dextrose Injection (8 mg/ 250 mL). The recall was issued because the outer overwrap label incorrectly states the product strength as 4 mg/ 250 mL, while the primary bag label correctly identifies it as 8 mg/ 250 mL. This drug is used for intravenous infusion, and a discrepancy in labeling could lead to significant medication errors.
If a healthcare provider relies on the incorrect overwrap label, a patient could receive twice the intended dose of norepinephrine. This is a potent medication used to increase blood pressure, and an overdose could lead to dangerously high blood pressure or other severe cardiovascular complications.
Hospital or clinical facility return coordination.
Rx Only. Recall #: D-0336-2024. Overwrap label incorrectly identified strength as 4 mg / 250 mL while bag label correctly identified it as 8 mg / 250 mL.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.