THE COMPOUNDING SHOP, INC. recalls Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Recalled June 12, 2013 · FDA recall D-551-2013 · THE COMPOUNDING SHOP
Hazard
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. · FDA Class II
Units
1 vial of 20mL and 1 vial of 40mL
Sold at
Florida, California, Minnesota, and Maine
Description
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product
Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, 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 →