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Denver Solutions, LLC DBA Leiters Health FDA Recalls
22 recalls on file across drugs, 6 of them Class I and 14 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, EnglewoClass IIMar 31, 2025Lack 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, Class IIMar 31, 2025Lack of Assurance of Sterility: Leaking/damaged syringes. |
| PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters HealtClass IIMar 31, 2025Lack 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, EnglewoClass IIMar 31, 2025Lack 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, EClass IIMar 31, 2025Lack of Assurance of Sterility: Leaking/damaged syringes. |
| Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Class IIFeb 20, 2024Presence of Particulate Matter: glass vials from the manufac |
| Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-09Class IIFeb 20, 2024Presence of Particulate Matter: glass vials from the manufac |
| Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 CompaClass IIFeb 20, 2024Presence of Particulate Matter: glass vials from the manufac |
| FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 1379Class IDec 28, 2023Superpotent Drug: semi-automated IV bag filling system can m |
| PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 CompClass IDec 28, 2023Superpotent Drug: semi-automated IV bag filling system can m |
| VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark BClass IDec 28, 2023Superpotent Drug: semi-automated IV bag filling system can m |
| VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Class IDec 28, 2023Superpotent Drug: semi-automated IV bag filling system can m |
| FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 1379Class IDec 28, 2023Superpotent Drug: semi-automated IV bag filling system can m |
| PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 ComClass IDec 28, 2023Superpotent Drug: semi-automated IV bag filling system can m |
| VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 ComparClass IIIOct 4, 2023Labeling: Not Elsewhere Classified |
| Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter CompoundingClass IIIOct 4, 2023Labeling: 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 ComparkClass IIIOct 4, 2023Labeling: Not Elsewhere Classified |
| Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDCClass IIFeb 21, 2023CGMP DEVIATIONS |
| Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDClass IIFeb 21, 2023CGMP DEVIATIONS |
| Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 CompaClass IIFeb 21, 2023CGMP DEVIATIONS |
| Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 137Class IIFeb 21, 2023CGMP DEVIATIONS |
| Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 ComClass IINov 29, 2021Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/m |