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Denver Solutions, LLC Recalls

22 recalls on record · December 29, 2021 to April 30, 2025 · Drugs

Recalls by year

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25

Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.

April 30, 2025DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, E
Hazard: Lack of Assurance of Sterility: Leaking/damaged syringes.
April 30, 2025DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewo
Hazard: Lack of Assurance of Sterility: Leaking/damaged syringes.
April 30, 2025DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Healt
Hazard: Lack of Assurance of Sterility: Leaking/damaged syringes.
April 30, 2025DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe,
Hazard: Lack of Assurance of Sterility: Leaking/damaged syringes.
April 30, 2025DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewo
Hazard: Lack of Assurance of Sterility: Leaking/damaged syringes.
March 6, 2024DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compa
Hazard: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
March 6, 2024DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-09
Hazard: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
March 6, 2024DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose
Hazard: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
February 7, 2024DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls 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
Hazard: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
February 7, 2024DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark
Hazard: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
February 7, 2024DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Com
Hazard: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
February 7, 2024DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Comp
Hazard: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
February 7, 2024DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 1379
Hazard: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
February 7, 2024DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 1379
Hazard: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
November 1, 2023DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark
Hazard: Labeling: Not Elsewhere Classified
November 1, 2023DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compar
Hazard: Labeling: Not Elsewhere Classified
November 1, 2023DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding
Hazard: Labeling: Not Elsewhere Classified
March 15, 2023DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 137
Hazard: CGMP DEVIATIONS
March 15, 2023DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compa
Hazard: CGMP DEVIATIONS
March 15, 2023DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC
Hazard: CGMP DEVIATIONS
March 15, 2023DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, ND
Hazard: CGMP DEVIATIONS
December 29, 2021DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Com
Hazard: Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Denver Solutions, LLC Recalls | RecallWatchUSA