Denver Solutions recalls
Denver Solutions appears in 22 official U.S. recall notices indexed by RecallRadar, most recently on 2025-04-30.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 22 |
|---|---|
| Published | 2021-12-29 to 2025-04-30 |
| By agency | FDA Drug (22) |
| By classification | Class II (13), Class I (6), Class III (3) |
| By status | ongoing (14), terminated (8) |
| Distribution named in notices | US |
Recalls
- PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Bl…
FDA Drug · Class II · 2025-04-30 · Denver Solutions
Reason: Lack of Assurance of Sterility: Leaking/damaged syringes. - dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters He…
FDA Drug · Class II · 2025-04-30 · Denver Solutions
Reason: Lack of Assurance of Sterility: Leaking/damaged syringes. - Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112
FDA Drug · Class II · 2025-04-30 · Denver Solutions
Reason: Lack of Assurance of Sterility: Leaking/damaged syringes. - Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112
FDA Drug · Class II · 2025-04-30 · Denver Solutions
Reason: Lack of Assurance of Sterility: Leaking/damaged syringes. - Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71…
FDA Drug · Class II · 2025-04-30 · Denver Solutions
Reason: Lack of Assurance of Sterility: Leaking/damaged syringes. - Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42
FDA Drug · Class II · 2024-03-06 · Denver Solutions
Reason: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. - Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood,…
FDA Drug · Class II · 2024-03-06 · Denver Solutions
Reason: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. - Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796…
FDA Drug · Class II · 2024-03-06 · Denver Solutions
Reason: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. - PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only
FDA Drug · Class I · 2024-02-07 · Denver Solutions
Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. - VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only
FDA Drug · Class I · 2024-02-07 · Denver Solutions
Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. - FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only
FDA Drug · Class I · 2024-02-07 · Denver Solutions
Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. - FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only
FDA Drug · Class I · 2024-02-07 · Denver Solutions
Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. - VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only
FDA Drug · Class I · 2024-02-07 · Denver Solutions
Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. - PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only
FDA Drug · Class I · 2024-02-07 · Denver Solutions
Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. - VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood,…
FDA Drug · Class III · 2023-11-01 · Denver Solutions
Reason: Labeling: Not Elsewhere Classified - VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, C…
FDA Drug · Class III · 2023-11-01 · Denver Solutions
Reason: Labeling: Not Elsewhere Classified - Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Comp…
FDA Drug · Class III · 2023-11-01 · Denver Solutions
Reason: Labeling: Not Elsewhere Classified - Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11
FDA Drug · Class II · 2023-03-15 · Denver Solutions
Reason: CGMP DEVIATIONS - Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Eng…
FDA Drug · Class II · 2023-03-15 · Denver Solutions
Reason: CGMP DEVIATIONS - Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15
FDA Drug · Class II · 2023-03-15 · Denver Solutions
Reason: CGMP DEVIATIONS - Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO…
FDA Drug · Class II · 2023-03-15 · Denver Solutions
Reason: CGMP DEVIATIONS - Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewoo…
FDA Drug · Class II · 2021-12-29 · Denver Solutions
Reason: Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL