Norepinephrine Bitartrate Injection Recalled for Defective Container
Athenex Pharma Solutions recalls Norepinephrine Bitartrate Injection due to defective container issues. The recall affects 5,320 bags distributed nationwide.
What this means for you
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 an FDA Class II recall for a defective container issue. The source text does not report any illnesses, injuries, or hospitalizations. According to the rubric, Class II recalls without reported harm typically receive a score of 2, as the hazard is facility-related rather than involving high-risk pathogens or critical labeling errors.
Plain-English summary
Athenex Pharma Solutions, LLC is recalling Norepinephrine Bitartrate Injection 16 mg per 250 mL added to 0.9% Sodium Chloride in 250 mL excel bags due to a defective container. The recall involves 5,320 bags that were distributed nationwide.
The affected lots are: F2101634 (expiration 3/30/22), F2101665 and F2101666 (expiration 4/02/22), F2101788 and F2101789 (expiration 4/26/22), and F2101811, F2101812, and F2101815 (expiration 4/29/22). The product has NDC number 76154-476-15.
This is a Class II recall initiated voluntarily by the firm on March 14, 2022. Healthcare providers and patients who have received this product should contact their healthcare provider or pharmacist for guidance. The recall was terminated on August 4, 2022.
The recalled product
- Product
- Norepinephrine Bitartrate Injection 16 mg per 250 mL added to 0.9% Sodium Chloride, 16 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-476-15
- Manufacturer
- Athenex Pharma Solutions, LLC
- Hazard
- defective-container
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 (12)
- Lot #: F2101634
- Exp 3/30/22
- F2101665
- F2101666
- Exp 4/02/22
- F2101788
- F2101789
- Exp 4/26/22
- F2101811
- F2101812
- F2101815
- Exp 4/29/22
Distribution
Distributed nationwide across the United States.
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