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QuVa Pharma, Inc.

FDA Regulatory Profile

Summary

Total Recalls
37 (2 Class I)
510(k) Clearances
0
Inspections
13
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0113-2026Class IIR.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium ChloridOctober 10, 2025
D-0295-2025Class IIfentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml March 6, 2025
D-0297-2025Class IIfentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml March 6, 2025
D-0296-2025Class IIfentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 10March 6, 2025
D-1544-2022Class IIIoxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High ASeptember 20, 2022
D-1302-2020Class IIoxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx onlyMay 28, 2020
D-1335-2020Class IIIR.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mLApril 23, 2020
D-0551-2020Class IIfentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 WNovember 12, 2019
D-0566-2020Class IIfentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 WNovember 12, 2019
D-0552-2020Class IIfentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium ChlorNovember 12, 2019
D-0571-2020Class IIfentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVANovember 12, 2019
D-0562-2020Class IIfentaNYL 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL) in 0.9% Sodium ChlorNovember 12, 2019
D-0569-2020Class IIfentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park OneNovember 12, 2019
D-0549-2020Class IIfentaNYL 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% SoNovember 12, 2019
D-0556-2020Class IIfentaNYL 100 mcg/2 mL (50 mcg/mL) Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, SuiNovember 12, 2019
D-0559-2020Class IIfentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium ChlorNovember 12, 2019
D-0564-2020Class IIfentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) in 0.9% Sodium ChlorNovember 12, 2019
D-0567-2020Class IIfentaNYL 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA PNovember 12, 2019
D-0557-2020Class IIfentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium November 12, 2019
D-0565-2020Class IIfentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium ChlorNovember 12, 2019