Nephron Sterile Compounding Center LLC recalls Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringe, 5 x 4 mL Pre-Filled Syri
Recalled June 8, 2022 · FDA recall D-0961-2022 · Nephron Sterile Compounding Center
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
115640 syringes
Sold at
Nationwide in the USA
Description
Lack of Assurance of Sterility
Product
Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringe, 5 x 4 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04
Manufacturer(s)
Nephron Sterile Compounding Center LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →