Nephron Sterile Compounding Center LLC recalls PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street E
Recalled November 23, 2022 · FDA recall D-0064-2023 · Nephron Sterile Compounding Center
Hazard
CGMP Deviations: Potential for cross contamination due to product carry over. · FDA Class II
Units
34,020 vials
Sold at
Nationwide in the USA
Description
CGMP Deviations: Potential for cross contamination due to product carry over.
Product
PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.
Manufacturer(s)
Nephron Sterile Compounding Center LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →