Hydromorphone 35 mg/ml + Bupivacaine 10 mg/ml + Baclofen 1,500 mcg/ml + Clonidine 200 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Recall Number: D-1672-2015

Firm: The Compounding Pharmacy of America

Classification: Class II

Status: Terminated

Report Date: 20150923

Initiation Date: 20150602

Termination Date: 20160210

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Hydromorphone 35 mg/ml + Bupivacaine 10 mg/ml + Baclofen 1,500 mcg/ml + Clonidine 200 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN