Eagle Pharma phenylephrine infusion recalled over sterility concerns
Eagle Pharma Outsourcing is recalling 50 single-use 250 mL containers of phenylephrine HCl infusion, lot PHENYL100-1004, expiring 12/31/2026. The product was distributed nationwide. The company cannot assure that the product is sterile, and no injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Check inventory for phenylephrine HCl infusion lot PHENYL100-1004 (exp. 12/31/2026).
- Do not administer any product from this lot.
- Quarantine affected containers and contact Eagle Pharma Outsourcing about return or disposal.
Is yours affected?
Compare your label or packaging with 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
- Sold in
- Nationwide
- Made for
- Adults (under 0 months)
This recall covers 2 products — see all of them.
Details
- Units affected
- 50 250 mL-containers
- Illnesses reported
- None reported
- Manufactured in
- 2200 Riverchase Ctr Ste 675, Hoover, Alabama, United States
- Classification
- Class II
- Recall number
- D-0105-2027
In the FDA's words
- Description
- 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 Lack of Assurance of Sterility Lot: PHENYL100-1004, Expiry: 12/31/2026. Distribution: Nationwide within the U.S Affected quantity: 50 250 mL-containers
- Hazard
- Lack of Assurance of Sterility
2 products in this recall
Eagle Pharma phenylephrine and oxytocin infusions recalled for sterility risk
Eagle Pharma Outsourcing is recalling two compounded IV infusion products nationwide: phenylephrine HCl (100 mg in 250 mL saline, 50 containers) and oxytocin (30 units in 500 mL saline, 5 containers). The company cannot assure that the products are sterile. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- 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 Riv… (this page)D-0105-2027 · 50 250 mL-containers
- OXYTOCIN, 30 USP UNITS, Added to 0.9% Sodium Chloride 500 mL - Single-Use Container, Rx Only, EAGLE PHARMA OUTSOURCING, 2200 Riverchase Center, Suite 675, Ho…D-0106-2027 · 5 500-mL containers