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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-0725-2020Class IICLON 800MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0764-2020Class IIQUADMIX 30MG/2MG/20MCG/100MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800December 20, 2019
D-0724-2020Class IICLON 750MCG/MORP 30MG/SUF 37.5MCG/ML in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0670-2020Class IIBAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0748-2020Class IIIPAMORELIN 2000MCG/ML INJ in 2 mL vial Assurance Infusion (713) 533-8800December 20, 2019
D-0697-2020Class IIBUP 2MG/ HYDROM 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0731-2020Class IIFENTANYL 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0706-2020Class IIBUP 3 mg/MORP 15 mg/mL Inj. in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0770-2020Class IITESTOSTERONE CYP 200MG/ML OIL in 10 mL vial Assurance Infusion (713) 533-8800December 20, 2019
D-0705-2020Class IIBUP 3MG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0774-2020Class IITRIMIX (UA) 30MG/1MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800December 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-0663-2020Class IIAutologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-8800December 20, 2019
D-0735-2020Class IIHCG 10,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800December 20, 2019
D-0709-2020Class IIBUP 40MG/MORP 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0685-2020Class IIBUP 15MG/CLON 600MCG/MORP 30MG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0679-2020Class IIBPC-157 2000 mcg/mL in 5 mL vials Assurance Infusion (713) 533-8800December 20, 2019
D-0713-2020Class IIBUP 5MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0703-2020Class IIBUP 35MG/FENT 1.5MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0667-2020Class IIBAC 200MCG/ CLONI 250MCG/ MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019