FDA Drug Class II — Moderate

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

Hazard

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

Products

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 70092-1
Brand
QuVa Pharma, Inc.
UPC
Lots: 10029829 Exp. 11/18/2019, 10029883 Exp. 11/19/2019, 10029829 Exp. 11/18/2019, 10029883 Exp. 11/19/2019, 10030056 Exp. 11/24/2019, 10029883 Exp. 11/19/2019, 10030867 Exp. 11/27/2019, 10030056 Exp. 11/24/2019, 10031005 Exp. 12/4/2019, 10030950 Exp. 12/3/2019, 10031005 Exp. 12/4/2019, 10031103 Exp. 12/6/2019, 10031006 Exp. 12/4/2019, 10031142 Exp. 12/8/2019, 10031274 Exp. 12/10/2019, 10031710 Exp. 12/12/2019, 10031628 Exp. 12/19/2019, 10031777 Exp. 12/22/2019, 10031683 Exp. 12/22/2019, 10032050 Exp. 12/29/2019, 10032051 Exp. 12/29/2019, 10032435 Exp. 1/2/2020, 10032468 Exp. 1/2/2020, 10032545 Exp. 1/5/2020, 10032676 Exp. 1/8/2020, 10032677 Exp. 1/8/2020, 10032595 Exp. 1/6/2020, 10032545 Exp. 1/5/2020, 10032596 Exp. 1/6/2020