Home / Recalls / Exela Pharma Sciences LLC / D-0118-2024

D-0118-2024 Class I Ongoing

Recalled by Exela Pharma Sciences LLC — Lenoir, NC

Recall Details

Product Type
Drugs
Report Date
November 29, 2023
Initiation Date
October 18, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
38,200 vials

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

Distribution Pattern

Nationwide

Code Information

Lot # 10000798, Expiration Date 03/31/2025

Other recalls by Exela Pharma Sciences LLC

  • D-0620-2025 Class II — 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenou (July 30, 2025)
  • D-0303-2025 Class II — 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Sing (March 7, 2025)
  • D-0117-2024 Class I — Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Singl (October 18, 2023)
  • D-0116-2024 Class I — 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Sing (October 18, 2023)
  • D-0079-2023 Class I — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose (November 28, 2022)
  • D-0080-2023 Class I — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose (November 28, 2022)
  • D-0023-2023 Class I — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose (October 4, 2022)
  • D-0022-2023 Class I — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose (October 4, 2022)
  • D-0369-2022 Class II — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx (January 11, 2022)
  • D-1585-2020 Class III — Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx o (May 5, 2020)