Phenylephrine HCl Injection Recalled Due to Defective Container
Athenex Pharma Solutions is recalling one lot of Phenylephrine HCl Injection due to a defective container. The recall affects 670 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: The recall is classified as FDA Class II by the agency. However, the source text does not report any illnesses, injuries, or deaths, and the hazard is described only as a defective container without specification of the nature or likelihood of harm. Under the rubric, a Class II recall without reported hospitalization falls below the Severe threshold. This is a voluntary precautionary recall grounded in a product defect, supporting a Moderate classification.
Plain-English summary
Athenex Pharma Solutions, LLC is recalling Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride (NDC 76154-493-15) due to a defective container. The affected lot is F2101651 with an expiration date of 5/30/22. A total of 670 bags were distributed nationwide.
The defective container poses a potential risk to patient safety. This is a Class II recall, meaning the product could cause serious adverse health consequences or death.
Consumers who have received or dispensed this product should stop using it immediately. Healthcare providers and patients should contact their pharmacy or healthcare facility if they have questions about whether they have received product from this recall.
The recalled product
- Product
- Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride, 40 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-493-15
- Manufacturer
- Athenex Pharma Solutions, LLC
- Category
- Drug — Injectable / Injection
- Hazard
- Affected units
- 670
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 #: F2101651
- Exp 5/30/22
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Athenex Pharma Solutions, 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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