Nephron Sterile Compounding Center LLC recalls Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle
Recalled March 8, 2023 · FDA recall D-0362-2023 · Nephron Sterile Compounding Center
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
10,980 bottles
Sold at
Nationwide in the USA
Description
Lack of Assurance of Sterility
Product
Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-321-25.
Manufacturer(s)
Nephron Sterile Compounding Center LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →