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).
Reported: November 29, 2023 Initiated: October 18, 2023 #D-0118-2024
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).
Reason for Recall
Presence of Particulate Matter: Silicone
Details
- Recalling Firm
- Exela Pharma Sciences LLC
- Units Affected
- 38,200 vials
- Distribution
- Nationwide
- Location
- Lenoir, NC
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Exela Pharma Sciences LLC. Units affected: 38,200 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: Silicone
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 29, 2023. Severity: Critical. Recall number: D-0118-2024.
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