Drug recall D-0118-2024

Class I Ongoing reported Nov 29, 2023

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).

Reason for recall

Presence of Particulate Matter: Silicone

Lots and codes

Lot # 10000798, Expiration Date 03/31/2025

Recall details

Recalling firm
Exela Pharma Sciences LLC, Lenoir, NC
Quantity
38,200 vials
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
October 18, 2023

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