FDA Drug Recalls

Recalls / Firms / Denver Solutions, LLC DBA Leiters Health

Denver Solutions, LLC DBA Leiters Health

22 FDA drug recalls on record — 6 Class I.

DateClassDrugStatus
2025-03-31Class IIKetamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters HealtOngoing
2025-03-31Class IIGlycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters HealtOngoing
2025-03-31Class IIRocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, LeitersOngoing
2025-03-31Class IIPHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose SOngoing
2025-03-31Class IIdexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per Ongoing
2024-02-20Class IILidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose VialOngoing
2024-02-20Class IIMoxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, EngOngoing
2024-02-20Class IIMoxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, IntracOngoing
2023-12-28Class IPHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for Ongoing
2023-12-28Class IFentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355,Ongoing
2023-12-28Class IPHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IOngoing
2023-12-28Class IVANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV usOngoing
2023-12-28Class IVANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV useOngoing
2023-12-28Class IFentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342,Ongoing
2023-10-04Class IIIOxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mLTerminated
2023-10-04Class IIIVANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters ComTerminated
2023-10-04Class IIIVANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters CoTerminated
2023-02-21Class IIPhenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 ComparTerminated
2023-02-21Class IIPhenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Terminated
2023-02-21Class IIPhenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Terminated
2023-02-21Class IIPhenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 CompaTerminated
2021-11-29Class IIMoxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/cartTerminated