FDA Drug Class II — Moderate

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1259-75

Hazard

Lack of Assurance of Sterility

Products

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Instit
Brand
QuVa Pharma, Inc.
UPC
Lot, expiry: Lot 10140303, exp 04/14/2025; Lots 10140867, 10140868, exp 04/24/2025; Lot 10140965, exp 04/28/2025

Units Affected

1,765 cassettes