Denver Solutions, LLC DBA Leiters Health

FDA Regulatory Profile

Summary

Total Recalls
22 (6 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0373-2025Class IIKetamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 CMarch 31, 2025
D-0372-2025Class IIPHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, RxMarch 31, 2025
D-0371-2025Class IIdexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL SMarch 31, 2025
D-0370-2025Class IIGlycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 CMarch 31, 2025
D-0374-2025Class IIRocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 1March 31, 2025
D-0361-2024Class IIMoxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral UseFebruary 20, 2024
D-0363-2024Class IILidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only,February 20, 2024
D-0362-2024Class IIMoxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, COFebruary 20, 2024
D-0282-2024Class IVANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; LeiDecember 28, 2023
D-0280-2024Class IPHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use onlDecember 28, 2023
D-0278-2024Class IFentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV usDecember 28, 2023
D-0281-2024Class IVANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; LeDecember 28, 2023
D-0277-2024Class IFentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV usDecember 28, 2023
D-0279-2024Class IPHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use onlyDecember 28, 2023
D-0070-2024Class IIIOxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx onlyOctober 4, 2023
D-0072-2024Class IIIVANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding HOctober 4, 2023
D-0071-2024Class IIIVANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding October 4, 2023
D-0445-2023Class IIPhenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters CoFebruary 21, 2023
D-0444-2023Class IIPhenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter CompoundinFebruary 21, 2023
D-0442-2023Class IIPhenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd EnFebruary 21, 2023