THE COMPOUNDING SHOP, INC. recalls Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Peter
Recalled June 12, 2013 · FDA recall D-556-2013 · THE COMPOUNDING SHOP
Hazard
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes · FDA Class II
Units
12 vials of 4mL, 1 vial of 6 mL, 1 vial of 8 mLand 3 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
Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, 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 →