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.

Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag Recalled by Denver Solutions, LLC DBA Leiters Health Due to CGMP DEVIATIONS

Date: February 21, 2023
Company: Denver Solutions, LLC DBA Leiters Health
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 Denver Solutions, LLC DBA Leiters Health directly.

Affected Products

Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94

Quantity: 8,136 units

Why Was This Recalled?

CGMP DEVIATIONS

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Denver Solutions, LLC DBA Leiters Health

Denver Solutions, LLC DBA Leiters Health has 22 total recalls tracked by RecallDetector.

Related Recalls

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