Nephron Sterile Compounding Center LLC recalls Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged
Recalled March 8, 2023 · FDA recall D-0355-2023 · Nephron Sterile Compounding Center
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
4,743 bottles
Sold at
Nationwide in the USA
Description
Lack of Assurance of Sterility
Product
Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 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 69374-997-15.
Manufacturer(s)
Nephron Sterile Compounding Center LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →