Nephron Sterile Compounding Center LLC recalls PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose
Recalled August 24, 2022 · FDA recall D-1347-2022 · Nephron Sterile Compounding Center
Hazard
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. · FDA Class II
Units
33,870 vials
Sold at
Nationwide in the USA
Description
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Product
PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34
Manufacturer(s)
Nephron Sterile Compounding Center LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →