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Assurance Infusion

FDA Regulatory Profile

Summary

Total Recalls
118
510(k) Clearances
0
Inspections
1
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0689-2020Class IIBUP 2.5MG/ CLONI 5MCG/ FENT 200MCG/ SUF 50MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713)December 20, 2019
D-0692-2020Class IIBUP 20MG/CLON 300MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0776-2020Class IITRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800December 20, 2019
D-0747-2020Class IIHYDROMORPHONE 6MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0743-2020Class IIHYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0730-2020Class IIFENTANYL 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0725-2020Class IICLON 800MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0769-2020Class IISUFENTANIL 55.5 MCG/ML IN 18ML INJ in 18 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0759-2020Class IIMORPHINE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0720-2020Class IICJC-1295 2000 mcg/Ipamorelin 2000 mcg/mL Inj. in 2 mL vial Assurance Infusion (713) 533-8800December 20, 2019
D-0718-2020Class IIBUP 8MG/CLON 100MCG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0753-2020Class IIMORPHINE 18MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0765-2020Class IIQUADMIX FORTE in 1 mL vial Assurance Infusion (713) 533-8800December 20, 2019
D-0758-2020Class IIMORPHINE 4MG/ML INJ in 20mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0755-2020Class IIMORPHINE 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0756-2020Class IIMORPHINE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0721-2020Class IICLON 100MCG/MORP 12MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0768-2020Class IISUFENTANIL 300MCG/ML INJ in 20 mL syringe Assurance Infusion (713)-533-8800December 20, 2019
D-0673-2020Class IIBAC 400MCG/BUP 20MG/HYDROM 15MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-88December 20, 2019
D-0738-2020Class IIHYDROM 17MG/PRIALT 5MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019