FDAFDA · Food and drugs·Recall number D-0118-2024
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).
Published November 29, 2023 · Recall initiated: October 18, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: Silicone
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ELCYS
- Manufacturer
- Exela Pharma Sciences LLC
- Distributor
- Nationwide
- Lot
- Lot # 10000798, Expiration Date 03/31/2025
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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