Drug Recall: NORepinephrine Injectable Due to Manufacturing Compliance Violations
Fresenius Kabi Compounding recalls 2,151 bags of NORepinephrine Bitartrate injectable due to manufacturing violations. The voluntary recall affects 125 healthcare accounts nationwide.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II FDA recall initiated voluntarily by the manufacturer due to manufacturing compliance violations. No illnesses, injuries, or confirmed contamination has been reported. The recall addresses a process compliance issue rather than a confirmed product defect.
Plain-English summary
Fresenius Kabi Compounding, LLC is recalling 2,151 bags of NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP (4 mg per 250 mL in single-dose bags). The recall was initiated due to violations of current Good Manufacturing Practice (cGMP) standards during production.
The recalled product, with lot number C274-000038582 (expiration date November 29, 2024), was distributed to 125 healthcare accounts nationwide. This is a prescription medication used in critical care settings.
This was a voluntary recall initiated by the manufacturer. Healthcare providers who received this product should immediately stop use and contact their supplier for return or destruction instructions. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58
- Manufacturer
- Fresenius Kabi Compounding, LLC
- Category
- Drug — Injectable / Vasopressor
- Hazard
- Affected units
- 2,151
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 # C274-000038582
- exp. date 29-Nov-24
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Fresenius Kabi Compounding, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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