Eagle Pharma Recalls Phenylephrine Infusion Due to Sterility Concerns
Eagle Pharma Outsourcing LLC is recalling Phenylephrine HCL Infusion due to a lack of assurance of sterility. The product was distributed nationwide in the U.S.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II due to a lack of assurance of sterility in a sterile infusion product. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Eagle Pharma Outsourcing LLC is recalling Phenylephrine HCL Infusion, 100 mg per 250 mL in 0.9% Sodium Chloride (0.4 mg/mL), Sterile, Rx Only, Single-Use Container. The recall is being conducted because of a lack of assurance of sterility. The affected product is identified by Lot PHENYL100-1004 and has an expiry date of 12/31/2026.
The recall involves 50 250 mL-containers. The product was distributed nationwide within the U.S. The FDA has classified this recall as Class II, which indicates that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and patients should stop using the affected product and contact Eagle Pharma Outsourcing LLC for further instructions. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- PHENYLephrine HCL Infusion, 100 mg per 250 mL in 0.9% Sodium Chloride (0.4 mg/mL), Sterile, Rx Only, Single-Use Container, EAGLE PHARMA OUTSOURCING, 2200 Riverchase Center, Suite 675, Hoover, AL 35244, UPC: 6985210025. NDC 69852-100-25
- Manufacturer
- Eagle Pharma Outsourcing LLC
- Category
- Drug — Infusion
- Hazard
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: PHENYL100-1004
- Expiry: 12/31/2026.
Distribution
Distributed nationwide across the United States.
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