Exela Pharma Sciences LLC recalls ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intraveno
Recalled November 29, 2023 · FDA recall D-0118-2024 · Exela Pharma Sciences
Hazard
Presence of Particulate Matter: Silicone · FDA Class I
Units
38,200 vials
Sold at
Nationwide
Description
Presence of Particulate Matter: Silicone
Product
ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous Infusion Only, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial: NDC 51754-1007-1; Carton: 51754-1007-3).
Manufacturer(s)
Exela Pharma Sciences LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →