Denver Solutions, LLC DBA Leiters Health Provisional
FDA Flags (22)
Class II RecallApr 2025
Denver Solutions, LLC DBA Leiters Health
Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, E
Classification: Class II
Class II RecallApr 2025
Denver Solutions, LLC DBA Leiters Health
dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe,
Classification: Class II
Class II RecallApr 2025
Denver Solutions, LLC DBA Leiters Health
Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewo
Classification: Class II
Class II RecallApr 2025
Denver Solutions, LLC DBA Leiters Health
Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewo
Classification: Class II
Class II RecallApr 2025
Denver Solutions, LLC DBA Leiters Health
PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Healt
Classification: Class II
Class II RecallMar 2024
Denver Solutions, LLC DBA Leiters Health
Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-09
Classification: Class II
Class II RecallMar 2024
Denver Solutions, LLC DBA Leiters Health
Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compa
Classification: Class II
Class II RecallMar 2024
Denver Solutions, LLC DBA Leiters Health
Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose
Classification: Class II
Class I RecallFeb 2024
Denver Solutions, LLC DBA Leiters Health
VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark
Classification: Class I
Class I RecallFeb 2024
Denver Solutions, LLC DBA Leiters Health
FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 1379
Classification: Class I
Class I RecallFeb 2024
Denver Solutions, LLC DBA Leiters Health
VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark B
Classification: Class I
Class I RecallFeb 2024
Denver Solutions, LLC DBA Leiters Health
FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 1379
Classification: Class I
Class I RecallFeb 2024
Denver Solutions, LLC DBA Leiters Health
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Comp
Classification: Class I
Class I RecallFeb 2024
Denver Solutions, LLC DBA Leiters Health
PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Com
Classification: Class I
Class III RecallNov 2023
Denver Solutions, LLC DBA Leiters Health
VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compar
Classification: Class III
Class III RecallNov 2023
Denver Solutions, LLC DBA Leiters Health
VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark
Classification: Class III
Class III RecallNov 2023
Denver Solutions, LLC DBA Leiters Health
Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding
Classification: Class III
Class II RecallMar 2023
Denver Solutions, LLC DBA Leiters Health
Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compa
Classification: Class II
Class II RecallMar 2023
Denver Solutions, LLC DBA Leiters Health
Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, ND
Classification: Class II
Class II RecallMar 2023
Denver Solutions, LLC DBA Leiters Health
Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC
Classification: Class II
Class II RecallMar 2023
Denver Solutions, LLC DBA Leiters Health
Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 137
Classification: Class II
Class II RecallDec 2021
Denver Solutions, LLC DBA Leiters Health
Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Com
Classification: Class II