Product: Hydromorphone 3 mg/ml + Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Reason for recall: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated: 20150602
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated