Home / Recalls / Nephron Sterile Compounding Center LLC / D-0257-2025

D-0257-2025 Class II Terminated

Recalled by Nephron Sterile Compounding Center LLC — West Columbia, SC

Recall Details

Product Type
Drugs
Report Date
March 19, 2025
Initiation Date
February 10, 2025
Termination Date
August 14, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,190 bottles

Product Description

Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50

Reason for Recall

Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.

Distribution Pattern

US Nationwide.

Code Information

Lot # NA4008B, exp. date 03/03/2025 Lot # NA4005B & NA4005E, exp. date 02/20/2025

Other recalls by Nephron Sterile Compounding Center LLC

  • D-0356-2023 Class II — Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (3 (February 22, 2023)
  • D-0358-2023 Class II — Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL ( (February 22, 2023)
  • D-0359-2023 Class II — Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Via (February 22, 2023)
  • D-0361-2023 Class II — Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vi (February 22, 2023)
  • D-0362-2023 Class II — Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/ (February 22, 2023)
  • D-0357-2023 Class II — Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (1 (February 22, 2023)
  • D-0360-2023 Class II — Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vi (February 22, 2023)
  • D-0355-2023 Class II — Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL (February 22, 2023)
  • D-0099-2023 Class II — Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe (January 6, 2023)
  • D-0065-2023 Class II — PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, N (November 10, 2022)