Home / Recalls / Denver Solutions, LLC DBA Leiters Health / D-0374-2025

D-0374-2025 Class II Ongoing

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

Recall Details

Product Type
Drugs
Report Date
April 30, 2025
Initiation Date
March 31, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16,655 syringes

Product Description

Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11

Reason for Recall

Lack of Assurance of Sterility: Leaking/damaged syringes.

Distribution Pattern

Nationwide in the U.S.A

Code Information

Lot #:2530023, Exp.: 7/12/2025

Other recalls by Denver Solutions, LLC DBA Leiters Health

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  • 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-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-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-0278-2024 Class I — FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), I (December 28, 2023)
  • D-0282-2024 Class I — VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, (December 28, 2023)
  • D-0281-2024 Class I — VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, (December 28, 2023)