Product: Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Reason for recall: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Recall initiated: 20130502
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated