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 E
Presence of Particulate Matter: Silicone
- Agency
- FDA Drug
- Recall date
- Oct 18, 2023
- Status
- Ongoing
- Company
- Exela Pharma Sciences LLC
1. What product was recalled?
8
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-4), For Intravenous Use Only, RX Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645; ALSO LABELED 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), c) 20x50 mL Single Dose Vials, (Vial NDC 72572-740-01; Carton NDC 72572-740-20), Rx Only, Mfd for: Civica, Inc., Lehi, Utah, 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.
Quantity: 355,220 vials
Code or lot text: a) P0001429, EXP 11/30/2023 b) P0001900, P0001902, EXP 08/31/2024; P0001903, P0001909, P0001945, EXP 09/30/2024; P0002002, EXP 11/30/2024; P0002052, EXP 12/31/2024 c) P0001912, EXP 08/31/2024
- LOT
- EXP 08/31/2024
- LOT
- EXP 09/30/2024
- LOT
- EXP 11/30/2023 b) P0001900
- LOT
- EXP 11/30/2024
- LOT
- EXP 12/31/2024 c) P0001912
- LOT
- P0001902
- LOT
- P0001903
- LOT
- P0001909
- LOT
- P0001945
- LOT
- P0002002
- LOT
- P0002052
- LOT
- a) P0001429
- NDC
- 51754-5001
- NDC
- 51754-5001-1
- NDC
- 51754-5001-4
- NDC
- 51754-5001-5
- NDC
- 51754-5002
- NDC
- 51754-5002-5
- NDC
- 51754-5011
- NDC
- 51754-5011-4
- NDC
- 51754-5012
- NDC
- 51754-5012-4
- NDC
- 72572-740-01
- NDC
- 72572-740-20
- RECALL-NUMBER
- D-0116-2024
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 E
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).
Quantity: 38,200 vials
Code or lot text: Lot # 10000798, Expiration Date 03/31/2025
- LOT
- Expiration Date 03/31/2025
- LOT
- Lot # 10000798
- NDC
- 51754-1007
- NDC
- 51754-1007-1
- NDC
- 51754-1007-3
- RECALL-NUMBER
- D-0118-2024
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
Presence of Particulate Matter: Silicone
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is urgent, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Drug source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.