fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride 100 mL CADD, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478NDC 70092-1259-75

Recall Number: D-0548-2020

Firm: QuVa Pharma, Inc.

Classification: Class II

Status: Terminated

Report Date: 20191211

Initiation Date: 20191112

Termination Date: 20200605

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride 100 mL CADD, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478NDC 70092-1259-75