Drug Enforcement D-0118-2024

Presence of Particulate Matter: Silicone

Status

Ongoing

Classification

Class I

Report Date

November 29, 2023

Termination Date

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Product Information

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).
Product quantity
38,200 vials
Reason for recall
Presence of Particulate Matter: Silicone
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Exela Pharma Sciences LLC
Address
1245 Blowing Rock Blvd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0118-2024
Event ID
93265
Recall initiation date
October 18, 2023
Center classification date
November 22, 2023
Code info
Lot # 10000798, Expiration Date 03/31/2025
More code info
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