Why it was recalled
Presence of Particulate Matter: Silicone
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 numbers, UPCs & expiration codes
Lot # 10000798, Expiration Date 03/31/2025
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0118-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Oct 18, 2023
- FDA report date
- Nov 29, 2023
- Quantity
- 38,200 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Exela Pharma Sciences LLC
Original FDA data
Every field from FDA enforcement report D-0118-2024, exactly as published.
Show all FDA fields
- City
- Lenoir
- State
- NC
- Status
- Ongoing
- Country
- United States
- Event ID
- 93265
- Address
- 1245 Blowing Rock Blvd
- Code information
- Lot # 10000798, Expiration Date 03/31/2025
- Postal code
- 28645-3618
- Report date
- Nov 29, 2023
- Product type
- Drugs
- Recall number
- D-0118-2024
- Classification
- Class I
- Recalling firm
- Exela Pharma Sciences LLC
- Product quantity
- 38,200 vials
- Reason for recall
- Presence of Particulate Matter: Silicone
- Voluntary / mandated
- Voluntary: Firm initiated
- 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).
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 18, 2023
- Initial firm notification
- Letter
- Center classification date
- Nov 22, 2023