Product: fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx only, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1160-37
Reason for recall: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Recall initiated: 20191112
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated