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.

PF-Labetalol HCl Injection Recalled by Nephron Sterile Compounding Center LLC Due to CGMP Deviations: Potential for cross contamination due to...

Date: November 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

PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.

Quantity: 34,020 vials

Why Was This Recalled?

CGMP Deviations: Potential for cross contamination due to product carry over.

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