Phenylephrine HCl Injection 50 mg Recalled for Defective Container
Athenex Pharma Solutions is voluntarily recalling Phenylephrine HCl Injection 50 mg in 250 mL excel bags distributed nationwide due to a defective container issue. The recall affects approximately 1,800 bags across three lots.
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 with no reported illnesses or injuries documented in the source text. The hazard is a structural/packaging defect that is precautionary in nature, meeting the criteria for a Moderate severity rating.
Plain-English summary
Athenex Pharma Solutions, LLC, located in Clarence, New York, is voluntarily recalling Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride in excel bags (NDC 76154-494-15) due to a defective container. The affected lots are F2101652 and F2101653 (expiration 5/30/22) and F2200111 (expiration 7/27/22). Approximately 1,800 bags were distributed nationwide.
The defective container may compromise the integrity of the product, which is a prescription injection medication used to treat low blood pressure. Patients and healthcare providers should not use the recalled product and should contact their pharmacy or healthcare facility for guidance on alternative products.
Athenex Pharma Solutions initiated this recall voluntarily and notified the FDA by letter on March 14, 2022. The FDA classified the recall as Class II on March 21, 2022. The recall was terminated on August 4, 2022.
The recalled product
- Product
- Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride, 50 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-494-15
- Manufacturer
- Athenex Pharma Solutions, LLC
- Hazard
- defective-container
- container-integrity
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 (5)
- Lot #: F2101652
- F2101653
- Exp 5/30/22
- F2200111
- Exp 7/27/22
Distribution
Distributed nationwide across the United States.
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