Home / Recalls / Exela Pharma Sciences LLC / D-0118-2024

D-0118-2024 Class I Ongoing

Recalled by Exela Pharma Sciences LLC — Lenoir, NC

FDA drug recall D-0118-2024 was initiated by Exela Pharma Sciences LLC on Oct 18, 2023 and is designated Class I. Reason for recall: Presence of Particulate Matter: Silicone The recall status is ongoing. Affected quantity: 38,200 vials.

Recall Details

Product Type: Drugs
Report Date: Nov 29, 2023
Initiation Date: Oct 18, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 38,200 vials

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

Distribution Pattern

Nationwide

Code Information

Lot # 10000798, Expiration Date 03/31/2025

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0118-2024
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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