FDA Drug recall D-1345-2022

Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, p…

• FDA Drug
• Class II
• terminated
• Published 2022-08-24

On 2022-08-24 the FDA classified a Class II recall of Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, p… by Nephron Sterile Compounding Center, citing CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.

Read the official FDA Drug notice

Product

Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in 1 x 1 IV bag per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-910-04

Reason

CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Other recalls by Nephron Sterile Compounding Center

• Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC…
  FDA Drug · Class II · 2025-03-19 · Nephron Sterile Compounding Center
• Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x…
  FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center
• Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per car…
  FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center
• Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12…
  FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center
• Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged i…
  FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center

All Nephron Sterile Compounding Center recalls

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1345-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.