The Recall Desk

FDA (Drugs) recall action 93178

Denver Solutions, LLC DBA Leiters Health recalled 3 products on 2023-11-01

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2023-11-01
Critical
0
Units
65,664

Why these products were recalled

Labeling: Not Elsewhere Classified

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • ModerateFDA (Drugs)··2023-11-01

    Oxytocin IV Bags Recalled Due to Labeling Defect

    Denver Solutions recalls 6,276 IV bags of oxytocin due to a labeling defect. The product was distributed nationwide to healthcare facilities.

    Product
    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
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2023-11-01

    Vancomycin Hydrochloride IV Bags Recalled Nationwide for Labeling Issue

    Denver Solutions, LLC is recalling 25,908 Vancomycin HCI IV bags distributed nationwide due to a labeling issue. Affected lots include products with expiration dates from October 2023 through January 2024.

    Product
    VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-029-68.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2023-11-01

    Vancomycin HCI IV bags recalled for labeling issue

    Denver Solutions is recalling 33,480 Vancomycin HCI IV bags (NDC 71449-028-68) due to a labeling issue. The affected lots were distributed nationwide.

    Product
    VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68.
    Category
    Distribution
    0 states