← FDA ENFORCEMENT
D-0118-2024Class I

Exela Pharma Sciences LLC

Recalling firm
Exela Pharma Sciences LLC
Product type
Drug
Status
Ongoing
Report date
2023-11-29
Distribution
Nationwide
Firm state
NC
Product quantity
38,200 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Presence of Particulate Matter: Silicone

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).

Code / lot info

Lot # 10000798, Expiration Date 03/31/2025

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See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.