Recalls / Class I
Class ID-0118-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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).
- Brand name
- Elcys
- Generic name
- Cysteine Hydrochloride
- Active ingredient
- Cysteine Hydrochloride
- Route
- Intravenous
- NDC
- 51754-1007
- FDA application
- NDA210660
- Affected lot / code info
- Lot # 10000798, Expiration Date 03/31/2025
Why it was recalled
Presence of Particulate Matter: Silicone
Recalling firm
- Firm
- Exela Pharma Sciences LLC
- Manufacturer
- Exela Pharma Sciences, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1245 Blowing Rock Blvd, N/A, Lenoir, North Carolina 28645-3618
Distribution
- Quantity
- 38,200 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2023-10-18
- FDA classified
- 2023-11-22
- Posted by FDA
- 2023-11-29
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0118-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.