FDA Recall D-0118-2024

Exela Pharma Sciences LLC · Lenoir, NC

Class I — life-threatening Ongoing 939 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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).

Lot / code: Lot # 10000798, Expiration Date 03/31/2025

Quantity: 38,200 vials

Reason for recall

Presence of Particulate Matter: Silicone

Recall record

Recall number: D-0118-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2023-10-18
Classified by FDA Center: 2023-11-22
FDA published: 2023-11-29
Recalling firm: Exela Pharma Sciences LLC
Firm location: Lenoir, NC

Drug identification

Brand name(s): ELCYS
Generic name(s): CYSTEINE HYDROCHLORIDE
Manufacturer(s): Exela Pharma Sciences, LLC
NDC(s): 51754-1007
Route(s): INTRAVENOUS

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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