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.

Fentanyl Citrate in 0.9% Sodium Chloride Injection Recalled by Nephron Sterile Compounding Center LLC Due to Lack of Assurance of Sterility

Date: May 18, 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

Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL), 150 mL IV Bag, 10 x 1 IV Bag, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21

Quantity: 3532 bags

Why Was This Recalled?

Lack of Assurance of Sterility

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.

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