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QuVa Pharma, Inc. recalls 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 FS

Recalled April 2, 2025 · FDA recall D-0297-2025 · QuVa Pharma

Hazard
Lack of Assurance of Sterility · FDA Class II
Units
1,765 cassettes
Sold at
U.S. Nationwide

Description

Lack of Assurance of Sterility

Product
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
Manufacturer(s)
QuVa Pharma, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

QuVa Pharma, Inc. recalls 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 FS | RecallWatchUSA