The Recall Desk

FDA (Drugs) recall action 91762

Denver Solutions, LLC DBA Leiters Health recalled 4 products on 2023-03-15

The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2023-03-15
Critical
0
Units
348,093

Why these products were recalled

CGMP DEVIATIONS

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.

States named across these recalls

1–4 of 4

  • ModerateFDA (Drugs)··2023-03-15

    FDA Class II: Phenylephrine Injection Recalled for Manufacturing Deviations

    Denver Solutions is recalling 325,300 units of Phenylephrine HCl injection due to Current Good Manufacturing Practice deviations. The product was distributed nationwide, including to government facilities.

    Product
    Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2023-03-15

    FDA Recalls Phenylephrine IV Solution for Manufacturing Practice Deviations

    Denver Solutions recalls 8,136 units of Phenylephrine HCl IV solution nationwide due to manufacturing practice deviations. The FDA classified this Class II recall as affecting prescription injectable solutions distributed to hospitals and government facilities.

    Product
    Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2023-03-15

    FDA Drug Recall: Phenylephrine IV Bags Recalled for Manufacturing Deviations

    Denver Solutions recalls 1,212 units of Phenylephrine HCl IV bags nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The voluntary recall affects products distributed across the U.S. including government facilities.

    Product
    Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2023-03-15

    Phenylephrine HCl syringe recalled for manufacturing practice deviations

    Phenylephrine HCl syringe recalled for manufacturing practice deviations. 13,445 units distributed nationwide were recalled by Denver Solutions, LLC.

    Product
    Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11
    Category
    Distribution
    1 state