Nephron Sterile Compounding Center LLC recalls Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose V
Recalled March 8, 2023 · FDA recall D-0361-2023 · Nephron Sterile Compounding Center
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
24,870 vials
Sold at
Nationwide in the USA
Description
Lack of Assurance of Sterility
Product
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-301-10.
Manufacturer(s)
Nephron Sterile Compounding Center LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →