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).
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # 10000798, Expiration Date 03/31/2025
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Exela Pharma Sciences LLC
- Reason for Recall:
- Presence of Particulate Matter: Silicone
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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 Codes/Lot Numbers:
Lot # 10000798, Expiration Date 03/31/2025
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0118-2024
Related Recalls
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Lack of Assurance of Sterility
Presence of Particulate Matter: Silicone