Intravenous norepinephrine drug recalled for incorrect concentration labeling
Baxter Healthcare is recalling 13,000 bags of norepinephrine bitartrate injection due to an overwrap label incorrectly showing 4 mg/250 mL concentration, while the primary bag label correctly shows the actual 8 mg/250 mL strength.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a critical-care intravenous medication with a significant labeling discrepancy that could lead to dosing confusion. With no reported illnesses or injuries, it qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling 13,000 bags of norepinephrine bitartrate injection due to a labeling discrepancy. The overwrap label incorrectly identifies the product strength as 4 mg per 250 mL; however, the primary bag label correctly identifies the product strength as 8 mg per 250 mL.
Norepinephrine bitartrate is an intravenous medication used in critical care settings to treat severe hypotension. The incorrect concentration labeling on the overwrap could lead to confusion during medication preparation and administration if healthcare providers rely on the overwrap instead of the primary bag label.
The affected product is lot 23I21G64 with an expiration date of July 31, 2024, distributed nationwide in the United States.
Healthcare providers should verify the concentration on the primary bag label before administering this medication. No illnesses or injuries have been reported to date.
The recalled product
- Product
- NOREPINEPHRINE BITARTRATE (NOREPINEPHRINE BITARTRATE)
- Brand
- NOREPINEPHRINE BITARTRATE
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Intravenous Medication
- Affected units
- 13,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 23I21G64
- Exp. 07/31/2024
Distribution
Distributed nationwide across the United States.
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