Elcys Injection, Solution
FDA Recall NDC 51754-1007
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Elcys (NDC 51754-1007). A significant event, classified as Class I, was initiated on Oct 18, 2023 by Exela Pharma Sciences, Llc. The reported reason for this action was: "Presence of Particulate Matter: Silicone"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class I Ongoing
Presence of Particulate Matter: Silicone
Oct 18, 2023
Nov 29, 2023
38,200 vials
Recall Profile & Regulatory Data
Event ID
93265
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Exela Pharma Sciences LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
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).
Batch or Lot Expiration Information
Lot# 10000798, Expiration Date 03/31/2025
Affected Packages Involved in this Recall
51754-1007-1Product
51754-1007-3Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
