QuVa Pharma, Inc. recalls fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CA
Recalled April 2, 2025 · FDA recall D-0296-2025 · QuVa Pharma
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
2,310 cassettes
Sold at
U.S. Nationwide
Description
Lack of Assurance of Sterility
Product
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 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: 70092-1255-75
Manufacturer(s)
QuVa Pharma, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →