Denver Solutions, LLC DBA Leiters Health recalls
FDA enforcement reports naming Denver Solutions, LLC DBA Leiters Health as the recalling firm.
- Recall reports
- 22
- Class I (serious)
- 6
- Most recent report
- Apr 30, 2025
- Apr 30, 2025Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leit…Drug · Denver Solutions, LLC DBA Leiters HealthLack of Assurance of Sterility: Leaking/damaged syringes.Class II
- Apr 30, 2025Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters He…Drug · Denver Solutions, LLC DBA Leiters HealthLack of Assurance of Sterility: Leaking/damaged syringes.Class II
- Apr 30, 2025PHENYLephrine HCl in 0Drug · Denver Solutions, LLC DBA Leiters HealthLack of Assurance of Sterility: Leaking/damaged syringes.Class II
- Apr 30, 2025dexmedeTOMIDine HCl PF, in 0Drug · Denver Solutions, LLC DBA Leiters HealthLack of Assurance of Sterility: Leaking/damaged syringes.Class II
- Apr 30, 2025Glycopyrrolate, 1mg per 5mL, (0Drug · Denver Solutions, LLC DBA Leiters HealthLack of Assurance of Sterility: Leaking/damaged syringes.Class II
- Mar 6, 2024Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd,…Drug · Denver Solutions, LLC DBA Leiters HealthPresence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.Class II
- Mar 6, 2024Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Int…Drug · Denver Solutions, LLC DBA Leiters HealthPresence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.Class II
- Mar 6, 2024Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1Drug · Denver Solutions, LLC DBA Leiters HealthPresence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.Class II
- Feb 7, 2024PHENYLephrine HCl 40 mg per 250 mL 0Drug · Denver Solutions, LLC DBA Leiters HealthSuperpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.Class I
- Feb 7, 2024FentaNYL citrate PF, 1000 mcg per 100 mL 0Drug · Denver Solutions, LLC DBA Leiters HealthSuperpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.Class I
- FentaNYL citrate PF, 2500 mcg per 250 mL 0
- PHENYLephrine HCl 20 mg per 250 mL 0
- VANCOmycin HCl PF 1
- VANCOmycin HCl PF 1
- VANCOmycin HCI PF, 1
- VANCOmycin HCI PF, 1
- Oxytocin synthetic, 30 Units added to 0
- Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Com…
- Phenylephrine HCl 0
- Phenylephrine HCl 20 mg (80 mcg/mL) added to 0
- Phenylephrine HCl 40 mg (160 mcg/mL) added to 0
- Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/c…
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