ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intraveno
Summary
The FDA issued a Class I for ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL by Exela Pharma Sciences LLC. Reason: Presence of Particulate Matter: Silicone.
Details
Source
Drug Recall
External ID
D-0118-2024
Action Date
2023-11-29
Status
Ongoing
Category
drug
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).
Lot/Code Info: Lot # 10000798, Expiration Date 03/31/2025
Quantity Affected: 38,200 vials
Reason for Recall
Presence of Particulate Matter: Silicone
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-18
Company
Lenoir, NC
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 38 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Exela Pharma Sciences LLC has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Exela Pharma Sciences LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Exela Pharma Sciences LLC have FDA actions?
Exela Pharma Sciences LLC has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0118-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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