Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Trisodium Citrate 0.5% Solution Recalled by Nephron Sterile Compounding Center LLC Due to CGMP Deviations: Potential for cross-contamination due to product...

Date: August 10, 2022
Company: Nephron Sterile Compounding Center LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Nephron Sterile Compounding Center LLC directly.

Affected Products

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

Quantity: 294 bags

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Nephron Sterile Compounding Center LLC

Nephron Sterile Compounding Center LLC has 73 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report