Epinephrine Injection recalled due to defective container
Athenex Pharma Solutions is recalling Epinephrine Injection 8 mg per 250 mL (excel bag) nationwide due to a defective container. The affected lots are F2101780 and F2101781, expiring 6/21/22.
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, and the source text does not report any illnesses or injuries. The hazard is a defective container rather than contamination or a high-risk pathogen, making this a moderate-severity voluntary precautionary recall.
Plain-English summary
Athenex Pharma Solutions, LLC (Clarence, NY) is recalling Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride, supplied in an excel bag. The recall affects two lots: F2101780 and F2101781, both expiring 6/21/22. The reason for the recall is a defective container.
The product has been distributed nationwide in the USA. This is a voluntary recall initiated by the firm.
Patients and healthcare providers who have received this product should contact their pharmacy or healthcare facility. The FDA classified this recall as Class II on March 21, 2022, and the recall was terminated on August 4, 2022.
The recalled product
- Product
- Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-814-15
- Manufacturer
- Athenex Pharma Solutions, LLC
- Category
- Drug — Injection
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 (3)
- Lot #: F2101780
- F2101781
- Exp 6/21/22
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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