FDA recall D-0118-2024

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

Distribution

Nationwide

Key facts

Status

Ongoing

Initiation date

2023-10-18

Report date

2023-11-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lenoir, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0118-2024