THE COMPOUNDING SHOP, INC. recalls Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Sho
Recalled June 12, 2013 · FDA recall D-572-2013 · THE COMPOUNDING SHOP
Hazard
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes · FDA Class II
Units
4 vials of 5mL and 22 vials of 10mL
Sold at
Florida, California, Minnesota, and Maine
Description
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product
Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL
Manufacturer(s)
THE COMPOUNDING SHOP, INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →