Norepinephrine Bitartrate in 5% Dextrose Injection recall
FDA recall D-0336-2024 · initiated Jan 23, 2024
Baxter Healthcare Corporation recalled Norepinephrine Bitartrate in 5% Dextrose Injection in Jan 2024 — an FDA Class II recall (D-0336-2024) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
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.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 13,000 bags
Details
- Product
- 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
- Recalling company
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jan 23, 2024
- FDA report date
- Feb 28, 2024
Frequently asked
- Was Norepinephrine Bitartrate in 5% Dextrose Injection recalled?
- Baxter Healthcare Corporation recalled Norepinephrine Bitartrate in 5% Dextrose Injection in Jan 2024 — an FDA Class II recall (D-0336-2024) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Norepinephrine Bitartrate in 5% Dextrose Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0336-2024 was: 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.
- Is a recalled Norepinephrine Bitartrate in 5% Dextrose Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Norepinephrine Bitartrate in 5% Dextrose Injection are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot 23I21G64; Exp. 07/31/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0336-2024.