Home / Recalls / Denver Solutions, LLC DBA Leiters Health / D-0281-2024

D-0281-2024 Class I Ongoing

Recalled by Denver Solutions, LLC DBA Leiters Health — Englewood, CO

Recall Details

Product Type
Drugs
Report Date
February 7, 2024
Initiation Date
December 28, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,152 IV bags

Product Description

VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.

Reason for Recall

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 2331184, Exp. Date 02/13/2024; 2331185, Exp. Date 02/10/2024; 2331189, Exp. Date 02/20/2024; 2331191, Exp. Date 02/24/2024; 2331258,Exp. Date 03/03/2024; 2331317, Exp. Date 03/15/2024.

Other recalls by Denver Solutions, LLC DBA Leiters Health

  • D-0374-2025 Class II — Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx onl (March 31, 2025)
  • D-0373-2025 Class II — Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Lei (March 31, 2025)
  • D-0372-2025 Class II — PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Sin (March 31, 2025)
  • D-0370-2025 Class II — Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Lei (March 31, 2025)
  • D-0371-2025 Class II — dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg ( (March 31, 2025)
  • D-0361-2024 Class II — Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injecti (February 20, 2024)
  • D-0363-2024 Class II — Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- (February 20, 2024)
  • D-0362-2024 Class II — Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark (February 20, 2024)
  • D-0277-2024 Class I — FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), I (December 28, 2023)
  • D-0280-2024 Class I — PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F (December 28, 2023)