Home / Recalls / Denver Solutions, LLC DBA Leiters Health / D-0070-2024

D-0070-2024 Class III Terminated

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

FDA drug recall D-0070-2024 was initiated by Denver Solutions, LLC DBA Leiters Health on October 4, 2023 and is designated Class III. Reason for recall: Labeling: Not Elsewhere Classified The recall status is terminated (terminated August 15, 2024). Affected quantity: 6,276 IV bags.

Recall Details

Product Type
Drugs
Report Date
November 1, 2023
Initiation Date
October 4, 2023
Termination Date
August 15, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,276 IV bags

Product Description

Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-157-70

Reason for Recall

Labeling: Not Elsewhere Classified

Distribution Pattern

USA Nationwide

Code Information

Lot#: 2330956, Exp. 10/23/2023; 2330964, Exp. 10/24/2023; 2331014, Exp. 11/6/2023; 2331033, Exp. 11/8/2023

Other recalls by Denver Solutions, LLC DBA Leiters Health

  • 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-0373-2025 Class II — Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Lei (March 31, 2025)
  • D-0374-2025 Class II — Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx onl (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-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-0361-2024 Class II — Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injecti (February 20, 2024)
  • 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)
  • D-0279-2024 Class I — PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3 (December 28, 2023)

FDA data resources