Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Recall Number: D-551-2013
Firm: THE COMPOUNDING SHOP, INC.
Classification: Class II
Status: Terminated
Report Date: 20130612
Initiation Date: 20130502
Termination Date: 20240930
Reason for Recall
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Description
Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL