ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Steri...
FDA Recall #D-0118-2024 — Class I — October 18, 2023
Product Description
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).
Reason for Recall
Presence of Particulate Matter: Silicone
Recalling Firm
Exela Pharma Sciences LLC — Lenoir, NC
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
38,200 vials
Distribution
Nationwide
Code Information
Lot # 10000798, Expiration Date 03/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated