Class I
Ongoing
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).
This recall is currently active, issued November 29, 2023. It was issued by Exela Pharma Sciences Llc.
- Company
- Exela Pharma Sciences Llc
- Recall Initiated
- October 18, 2023
- Posted
- November 29, 2023
- Recall Number
- D-0118-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 38,200 vials
- Firm Location
- Lenoir, NC, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of Particulate Matter: Silicone
Distribution
Nationwide
Lot / Code Info
Lot # 10000798, Expiration Date 03/31/2025
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