Drug product
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).
D-0118-2024
Product summary
- Event
- Event 93265
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 38,200 vials
- Official record key
drug-enforcement:D-0118-2024
Official wording
Reason: Presence of Particulate Matter: Silicone
Code information: Lot # 10000798, Expiration Date 03/31/2025
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter