Class II — Potential Health Hazard

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

Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil Recalled by THE COMPOUNDING SHOP, INC. Due to Lack of Assurance of Sterility: FDA inspection findings...

Date: May 2, 2013
Company: THE COMPOUNDING SHOP, INC.
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 THE COMPOUNDING SHOP, INC. directly.

Affected Products

Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL

Quantity: 4 vials of 5mL and 22 vials of 10mL

Why Was This Recalled?

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Where Was This Sold?

Florida, California, Minnesota, and Maine

About THE COMPOUNDING SHOP, INC.

THE COMPOUNDING SHOP, INC. has 25 total recalls tracked by RecallDetector.

Related Recalls

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