FDA-Drug2025-04-02Class II
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
QuVa Pharma, Inc.
Hazard
Lack of Assurance of Sterility
Sold states
U.S. Nationwide
Affected count
1,765 cassettes
Manufactured in
1075 W Park One Dr Ste 100, N/A, Sugar Land, TX, United States
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 Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1259-75
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0297-2025Don't want to check this manually?
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